| 1 |
NCT03066193 |
Recruiting |
Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome |
|
- Drug: Dronabinol
- Dietary Supplement: Palmotoyletahnolamide
|
Interventional |
Phase 3 |
- Yale University
- Therapix Biosciences Ltd.
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Improvement in Tic Severity
|
18 |
All |
18 Years to 60 Years (Adult) |
NCT03066193 |
1610018525 |
|
February 1, 2017 |
January 2018 |
January 2019 |
February 28, 2017 |
March 3, 2017 |
|
- Yale Child Study Center
New Haven, Connecticut, United States
|
| 2 |
NCT02569073 |
Recruiting |
Investigation of Cannabinoid Receptor Agonist Dronabinol in Patients With Functional Chest Pain |
|
- Drug: Dronabinol
- Drug: Placebo
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Treatment
|
- Chest Pain
- Chest Pain Intensity
- GERD Symptom Checklist
- (and 17 more...)
|
40 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02569073 |
22894 |
ICAMP |
June 21, 2017 |
October 2018 |
October 2020 |
October 6, 2015 |
July 31, 2017 |
|
- Temple University Hospital
Philadelphia, Pennsylvania, United States
|
| 3 |
NCT02792257 |
Recruiting |
Trial of Dronabinol Adjunctive Treatment of Agitation in Alzheimer's Disease (AD) (THC-AD) |
|
- Drug: Dronabinol (Marinol®)
- Drug: Placebo
|
Interventional |
Phase 2 |
- Johns Hopkins University
- Mclean Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Symptoms of agitation as measured by the Pittsburgh Agitation Scale
- Symptoms of agitation as measured by the Neuropsychiatric Inventory, Clinician Version
- Adverse events in Dronabinol treatment as compared to placebo
|
160 |
All |
60 Years to 90 Years (Adult, Senior) |
NCT02792257 |
IRB00052955 |
THC-AD |
March 1, 2017 |
August 2020 |
December 2020 |
June 7, 2016 |
October 27, 2017 |
|
- Johns Hopkins University
Baltimore, Maryland, United States - McLean Hospital
Belmont, Massachusetts, United States
|
| 4 |
NCT02608931 |
Recruiting |
The Safety, Tolerability and Efficacy of Dronabinol, for the Treatment of Nausea and Vomiting in Familial Dysautonomia |
- Nausea
- Vomiting
- Familial Dysautonomia
|
- Drug: Dronabinol
- Other: Placebo
|
Interventional |
Phase 2 |
- New York University School of Medicine
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Number of adverse effects
- Change in nausea scores
- Change in weight.
- Change in anxiety scores
|
25 |
All |
18 Years to 60 Years (Adult) |
NCT02608931 |
14-01577 |
|
November 2015 |
March 2018 |
March 2018 |
November 20, 2015 |
November 22, 2017 |
|
- NYU Medical Center
New York, New York, United States
|
| 5 |
NCT02460692 |
Recruiting |
Trial of Dronabinol and Vaporized Cannabis in Neuropathic Low Back Pain |
- Cannabis
- Low Back Pain
- Neuropathic Pain
|
- Drug: Placebos
- Drug: dronabinol
- Drug: Vaporized Cannabis 3.7% THC/5.6% CBD
|
Interventional |
Phase 2 |
- University of California, San Diego
- National Institute on Drug Abuse (NIDA)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Numerical Pain Intensity
- Repeated Measures Recommended Minimal Dataset (NIH Task Force on chronic low back pain)
- Neuropathic Pain Scale
- (and 10 more...)
|
120 |
All |
19 Years to 70 Years (Adult, Senior) |
NCT02460692 |
1R01DA038634-01A1
R01DA038634 |
|
September 2016 |
May 2020 |
May 2020 |
June 2, 2015 |
September 19, 2017 |
|
- UC Center for Medicinal Cannabis Research, UC San Diego
San Diego, California, United States
|
| 6 |
NCT02604992 |
Completed |
Comparative Bioavailability of Dronabinol Oral Solution in Healthy Volunteers |
|
- Drug: Treatment A
- Drug: Treatment B
- Drug: Treatment C
|
Interventional |
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Area under the curve from time 0 to the last measured concentration
- Area under the curve extrapolated to infinity
- Maximum plasma concentration
- (and 6 more...)
|
54 |
All |
18 Years to 50 Years (Adult) |
NCT02604992 |
INS004-15-059 |
|
November 2015 |
December 2015 |
December 2015 |
November 16, 2015 |
January 20, 2016 |
|
- Worldwide Clinical Trials Early Phase Services, LLC
San Antonio, Texas, United States
|
| 7 |
NCT02811510 |
Recruiting |
Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study I |
|
- Drug: Placebo
- Drug: Dronabinol
|
Interventional |
Phase 1 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Basic Science
|
- Change from Baseline: Rewarding Effects measured by Visual Analog Scale (VAS)
- Change from Baseline: Verbal Learning: Measured by Rey Auditory Verbal Learning Test (RAVLT)
|
40 |
All |
18 Years to 55 Years (Adult) |
NCT02811510 |
1505015940.A |
THC-Gender-I |
June 2016 |
June 2020 |
June 2020 |
June 23, 2016 |
February 23, 2017 |
|
- Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine
West Haven, Connecticut, United States
|
| 8 |
NCT03215940 |
Recruiting |
Treatment of Chronic Pain With Cannabidiol (CBD) and Delta-9-tetrahydrocannabinol (THC) |
|
- Drug: Delta-9-Tetrahydrocannabinol
- Drug: Cannabidiol
- Drug: Placebos
|
Interventional |
Early Phase 1 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Brain Changes
- Improvement in pain relief
|
75 |
All |
18 Years to 50 Years (Adult) |
NCT03215940 |
IRB_00103451 |
|
February 1, 2018 |
December 2018 |
February 2019 |
July 12, 2017 |
February 23, 2018 |
|
- University Of Utah
Salt Lake City, Utah, United States
|
| 9 |
NCT01598896 |
Recruiting |
Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia |
- Cannabis Dependence
- Marijuana Dependence
|
- Drug: Dronabinol
- Drug: Clonidine
- Drug: Placebo
|
Interventional |
Phase 2
Phase 3 |
- Mclean Hospital
- Brain & Behavior Research Foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from baseline in cannabis use at 10 weeks
- Change in withdrawal symptoms from baseline at 10 weeks
- Change from baseline in cannabis use at 14 weeks
- Change in withdrawal symptoms from baseline at 14 weeks
|
18 |
All |
18 Years to 45 Years (Adult) |
NCT01598896 |
2010P-002262
Brain and Behavior Research |
DCCS |
May 2012 |
August 2017 |
August 2017 |
May 15, 2012 |
April 27, 2017 |
|
- McLean Hospital
Belmont, Massachusetts, United States
|
| 10 |
NCT01394185 |
Completed
Has Results |
Effects of Dronabinol (Oral THC) on Cannabis Use |
|
- Drug: Dronabinol 120mg/day
- Drug: Placebo
- Drug: Dronabinol 240mg/day
|
Interventional |
Phase 1
Phase 2 |
- Johns Hopkins University
- National Institute on Drug Abuse (NIDA)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Basic Science
|
- Marijuana Self-administration - Progressive Ratio
- Marijuana Self-administration - Drug Vs Money Choice
|
25 |
All |
18 Years to 100 Years (Adult, Senior) |
NCT01394185 |
NA_00041251
R01DA025044 |
|
February 2011 |
September 2012 |
September 2012 |
July 14, 2011 |
August 3, 2017 |
August 3, 2017 |
- Johns Hopkins University (Bayview Campus)
Baltimore, Maryland, United States
|
| 11 |
NCT02094599 |
Completed |
A Study of the Abuse Potential of Dronabinol in Recreational Cannabinoid Users |
|
- Drug: Dronabinol 10 mg
- Drug: Dronabinol 30 mg
- Drug: Placebo
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
|
- Peak score (Emax) on Drug Liking calculated from a 100-point visual analogue scale (VAS), where 0=strong disliking and 100=strong liking
- Peak score (Emax) for Drug Effects, calculated from scores on a VAS scale of 0-100, where 0=not at all and 100=extremely
- Peak score (Emax) for a shortened Addiction Research Center Inventory (ARCI) scale of 0-49, where 49 is the highest possible score
- (and 9 more...)
|
43 |
All |
18 Years to 55 Years (Adult) |
NCT02094599 |
INS-13-017 |
|
February 2014 |
May 2014 |
May 2014 |
March 24, 2014 |
May 13, 2014 |
|
- INC Research Toronto, Inc.
Toronto, Ontario, Canada
|
| 12 |
NCT03098940 |
Not yet recruiting |
A Bioavailability Study on Dronabinol |
|
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
50 |
All |
18 Years to 55 Years (Adult) |
NCT03098940 |
MedChew |
|
January 2018 |
April 2018 |
September 2018 |
April 4, 2017 |
April 4, 2017 |
|
|
| 13 |
NCT01380457 |
Completed |
Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions |
- To Determine Bioequivalence Under Fasting Conditions
|
- Drug: Dronabinol
- Drug: Marinol
|
Interventional |
Phase 1 |
- Par Pharmaceutical, Inc.
- BASi Clinical Research Unit
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
|
|
69 |
All |
18 Years to 55 Years (Adult) |
NCT01380457 |
11885 |
|
January 2006 |
April 2006 |
April 2006 |
June 27, 2011 |
June 27, 2011 |
|
- BASi
Baltimore, Maryland, United States
|
| 14 |
NCT03008005 |
Recruiting |
Effects of Delta-9 Tetrahydrocannabinol (THC) on Retention of Memory for Fear Extinction Learning in PTSD: R61 Study |
- PostTraumatic Stress Disorder
|
- Drug: Placebo Oral Capsule
- Drug: Dronabinol Cap 5 milligrams (MG)
- Drug: Dronabinol Cap 10 milligrams (MG)
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Basic Science
|
- Brain Measures
- Psychophysiology
- Expectancy Ratings
- (and 8 more...)
|
104 |
All |
18 Years to 50 Years (Adult) |
NCT03008005 |
1R61MH111935-01 |
|
June 1, 2017 |
December 31, 2019 |
December 31, 2019 |
January 2, 2017 |
November 6, 2017 |
|
- Eugene Applebaum College of Pharmacy and Health Sciences
Detroit, Michigan, United States
|
| 15 |
NCT01093976 |
Completed
Has Results |
Marinol in Trichotillomania or Obsessive Compulsive Disorder |
- Trichotillomania
- Obsessive Compulsive Disorder
|
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Massachusetts General Hospital Hairpulling Scale (MGH-HPS) Total Score
|
14 |
All |
18 Years to 65 Years (Adult) |
NCT01093976 |
0909M72088 |
|
April 2010 |
January 2011 |
February 2011 |
March 26, 2010 |
September 27, 2013 |
September 27, 2013 |
- Ambulatory Research Center
Minneapolis, Minnesota, United States
|
| 16 |
NCT02472847 |
Completed
Has Results |
Cannabinoid Control of Fear Extinction Neural Circuits in Humans |
|
- Drug: Dronabinol
- Drug: Placebo
|
Interventional |
Phase 4 |
- University of Illinois at Chicago
- National Institute of Mental Health (NIMH)
- National Institutes of Health (NIH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Basic Science
|
- BOLD Signal Measured by Functional Magnetic Resonance Imaging (fMRI)
|
85 |
All |
21 Years to 45 Years (Adult) |
NCT02472847 |
2012-0242
R21MH093917 |
|
May 2012 |
July 2014 |
July 2014 |
June 16, 2015 |
August 25, 2015 |
August 25, 2015 |
|
| 17 |
NCT01448772 |
Completed |
Comparative Bioavailability of Dronabinol Oral Solution Versus Branded Capsule 5 mg Under Fasting Conditions |
|
- Drug: Dronabinol Capsules, 5 mg
- Drug: Dronabinol Oral Solution
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
|
- Rate and extent of absorption
|
88 |
All |
18 Years to 55 Years (Adult) |
NCT01448772 |
INS-10-012 |
|
October 2011 |
December 2011 |
December 2011 |
October 7, 2011 |
March 26, 2012 |
|
- Worldwide Clinical Trials Drug Development Solutions
Austin, Texas, United States
|
| 18 |
NCT01024335 |
Completed
Has Results |
Dronabinol Naltrexone Treatment for Opioid Dependence |
|
- Drug: injectable naltrexone and dronabinol
- Drug: Naltrexone and placebo
|
Interventional |
Phase 2
Phase 3 |
- New York State Psychiatric Institute
- National Institute on Drug Abuse (NIDA)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Opiate Withdrawal Measured by the Subjective Opiate Withdrawal Scale (SOWS) .
- Retention
|
60 |
All |
18 Years to 60 Years (Adult) |
NCT01024335 |
#5962 DA027124
R01DA027124
DPMC |
Domino |
January 2010 |
December 2012 |
December 2012 |
December 2, 2009 |
September 5, 2014 |
September 5, 2014 |
- New York State Psychiatric Institute
New York, New York, United States
|
| 19 |
NCT00959218 |
Completed |
Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Central Neuropathic Pain Related to Multiple Sclerosis |
- Central Neuropathic Pain in Multiple Sclerosis
|
- Drug: Dronabinol
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Mean change of baseline pain severity score on the 11-point Likert Numerical Rating Scale recorded in patient diary
- Likert Numerical Rating Scale pain relief
- Pain-related sleep interference
- (and 2 more...)
|
240 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT00959218 |
cnp-MS-0601 / MC-2006-01 |
|
June 2007 |
March 2010 |
April 2010 |
August 14, 2009 |
February 3, 2012 |
|
- Maerkische Kliniken GmbH, Klinikum Luedenscheid, Akademisches Lehrkrankenhaus der Universitaet Bonn, Klinik fuer Neurologie
Luedenscheid, Germany
|
| 20 |
NCT01020019 |
Completed
Has Results |
Combined Pharmacotherapy for Cannabis Dependency |
- Cannabis Dependence
- Marijuana Dependence
|
- Drug: Dronabinol
- Drug: Placebo
- Drug: Lofexidine
|
Interventional |
Phase 2
Phase 3 |
- New York State Psychiatric Institute
- National Institute on Drug Abuse (NIDA)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- 21 Days of Consecutive Abstinence as Measured by the Time-line Followback.
|
156 |
All |
18 Years to 60 Years (Adult) |
NCT01020019 |
#6015
P50DA009236-16 |
D-LUCS |
January 2010 |
September 2014 |
September 2014 |
November 25, 2009 |
April 6, 2018 |
May 11, 2016 |
- New York State Psychiatric Institute
New York, New York, United States
|
| 21 |
NCT02811939 |
Recruiting |
Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone: Sub-Study I |
|
- Drug: Active Dronabinol
- Drug: Active Pregnenolone
- Drug: Placebo Dronabinol
- Drug: Placebo Pregnenolone
|
Interventional |
Phase 1 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Basic Science
|
- Change from Baseline: Positive and Negative Syndrome Scale (PANSS)
- Change from Baseline: Clinician Administered Dissociative Symptoms Scale (CADSS)
- Change from Baseline: Visual Analog Scale (VAS)
- (and 2 more...)
|
19 |
All |
18 Years to 55 Years (Adult) |
NCT02811939 |
1501015242.A |
THC-PREG-I |
March 2016 |
February 2018 |
February 2018 |
June 23, 2016 |
June 23, 2017 |
|
- Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine
West Haven, Connecticut, United States
|
| 22 |
NCT03369639 |
Recruiting |
Study of Dronabinol Treatment for Depression and/or Anxiety in Older Patients |
|
|
Observational |
|
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Efficacy against depression as measured by the MADRS
- Efficacy against anxiety as measured by the HAM-A
- Incidence of treatment-emergent adverse effects (Safety)
- (and 3 more...)
|
45 |
All |
50 Years to 89 Years (Adult, Senior) |
NCT03369639 |
2017P001930 |
|
November 28, 2017 |
January 1, 2019 |
September 1, 2019 |
December 12, 2017 |
December 12, 2017 |
|
- McLean Hospital
Belmont, Massachusetts, United States
|
| 23 |
NCT02069366 |
Recruiting |
Cannabinoid Control of Fear Extinction Neural Circuits in Post-traumatic Stress Disorder |
- Post-Traumatic Stress Disorder
|
- Drug: Dronabinol
- Drug: Placebo
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Basic Science
|
- Brain Measures
- Psychophysiology
- Expectancy Ratings
- (and 3 more...)
|
120 |
All |
21 Years to 45 Years (Adult) |
NCT02069366 |
1K01MH101123-01A1 |
|
November 2014 |
March 2018 |
|
February 24, 2014 |
December 7, 2016 |
|
- Eugene Applebaum College of Pharmacy and Health Sciences
Detroit, Michigan, United States
|
| 24 |
NCT01832766 |
Terminated
Has Results |
The Effects of Cannabis Use in People With Schizophrenia on Clinical, Neuropsychological and Physiological Phenotypes |
|
- Drug: Dronabinol
- Other: Placebo Comparator
|
Interventional |
Phase 1
Phase 2 |
- University of Colorado, Denver
- National Alliance for Research on Schizophrenia and Depression
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
|
- P50 Auditory Evoked Potential
- California Verbal Learning Test Change at 2 Hours From Baseline
|
13 |
All |
18 Years to 50 Years (Adult) |
NCT01832766 |
05-0359 |
|
June 2005 |
May 2010 |
May 2011 |
April 16, 2013 |
September 21, 2015 |
September 21, 2015 |
- University of Colorado Denver
Aurora, Colorado, United States
|
| 25 |
NCT00946348 |
Completed
Has Results |
Cannabis and Schizophrenia: Self-Medication and Agonist Treatment |
- Schizophrenia
- Dual Diagnosis
- Schizoaffective Disorder
- (and 2 more...)
|
- Drug: Dronabinol
- Drug: Cannabis
|
Interventional |
Phase 1 |
- Dartmouth-Hitchcock Medical Center
- National Institute on Drug Abuse (NIDA)
- Indiana University
- (and 3 more...)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Basic Science
|
- fMRI Connectivity of Regions of Interest (ROI) Within the Brain Reward Circuitry (BRC).
- To Assess the Effects of Dronabinol in This Population to Determine Whether Measures of Craving, Mood and Negative Symptoms Will Improve Using the PANSS; and to Determine Whether Measures of Psychotic Symptoms and Cognitive Deficits Will Increase.
|
12 |
All |
18 Years to 50 Years (Adult) |
NCT00946348 |
R01DA013196
1R01DA026799-01
R01DA026799-01
DPMC |
|
December 2009 |
October 2012 |
October 2012 |
July 27, 2009 |
March 14, 2018 |
September 29, 2014 |
- Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
|
| 26 |
NCT00480441 |
Completed |
Effectiveness Study of Dronabinol and BRENDA for the Treatment of Cannabis Withdrawal |
|
- Drug: Dronabinol
- Behavioral: BRENDA therapy
- Drug: Placebo
|
Interventional |
Phase 2 |
- University of Pennsylvania
- National Institute on Drug Abuse (NIDA)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Cannabis dependent patients will be able to tolerate dronabinol.
- Dronabinol will attenuate cannabis withdrawal.
- The quantitative THC and self-report measurements will decrease over the time of study.
- (and 4 more...)
|
61 |
All |
18 Years to 55 Years (Adult) |
NCT00480441 |
5P60DA005186-19 |
|
August 2006 |
June 2009 |
July 2009 |
May 31, 2007 |
January 18, 2012 |
|
- Treatment Research Center at the University of Pennsylvania
Philadelphia, Pennsylvania, United States
|
| 27 |
NCT01253408 |
Completed
Has Results |
Effect of Cannabinoid Agonist on Gastrointestinal and Colonic Motor Functions in Patients With Irritable Bowel Syndrome (IBS) |
|
- Drug: Dronabinol
- Drug: Placebo
|
Interventional |
Phase 2 |
- Mayo Clinic
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- National Center for Research Resources (NCRR)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
|
- Colonic Transit Geometric Center at 24 Hours
- Colonic Transit Geometric Center
- Gastric Emptying Half-Time (t1/2)
- (and 3 more...)
|
36 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01253408 |
08-008314 Part A
R01DK079866
UL1RR024150 |
|
September 2009 |
December 2011 |
December 2011 |
December 3, 2010 |
May 7, 2013 |
May 7, 2013 |
- Mayo Clinic
Rochester, Minnesota, United States
|
| 28 |
NCT00217971 |
Completed
Has Results |
Dronabinol Treatment for Marijuana Addiction |
|
- Drug: Dronabinol
- Drug: Placebo
|
Interventional |
Phase 2 |
- New York State Psychiatric Institute
- National Institute on Drug Abuse (NIDA)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial
|
156 |
All |
18 Years to 60 Years (Adult) |
NCT00217971 |
#4886-NIDA-09236-11
P50DA009236
P50DA009236-11
DPMC |
MARINOL |
March 2005 |
December 2009 |
December 2009 |
September 22, 2005 |
April 8, 2016 |
November 1, 2011 |
- Research Foundation for Mental Hygiene, Inc.
New York, New York, United States
|
| 29 |
NCT00418925 |
Unknown † |
Efficacy of Dronabinol for the Treatment of Cervical Dystonia |
|
|
Interventional |
Phase 2 |
- University Health Network, Toronto
- Dystonia Medical Research Foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)with 3 weeks of active treatment compared to placebo
- To determine the rate and severity of adverse events within and between participants
- To observe changes within and between participants in the Global Impression Scale (GIS)
- To observe changes within and between participants in the Visual Analog Pain Scale
|
38 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT00418925 |
MDC DRO 2006 |
|
September 2006 |
November 2009 |
December 2009 |
January 5, 2007 |
September 9, 2008 |
|
- Toronto Western Hospital
Toronto, Ontario, Canada
|
| 30 |
NCT00314808 |
Completed
Has Results |
A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas |
- Brain Neoplasms
- Nausea
- Vomiting
|
|
Interventional |
Phase 1 |
- Duke University
- Solvay Pharmaceuticals
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Tolerability Rate
- Unacceptable Toxicity Rate
- Mean Change From Baseline in Quality of Life -- FACT-Br
- (and 2 more...)
|
33 |
All |
18 Years and older (Adult, Senior) |
NCT00314808 |
Pro00007559
7136-05-6R0 |
|
April 2006 |
October 2011 |
April 2012 |
April 17, 2006 |
July 16, 2014 |
August 6, 2013 |
- Preston Robert Tisch Brain Tumor Center at Duke University Medical Center
Durham, North Carolina, United States
|
| 31 |
NCT01149018 |
Unknown † |
Efficacy Trial of Oral Tetrahydrocannabinol in Patients With Fibromyalgia |
|
- Drug: Tetrahydrocannabinol
- Drug: Placebo
|
Interventional |
Not Applicable |
- Hadassah Medical Organization
- Hebrew University of Jerusalem
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Meaningful change in Total score on Fibromyalgia Impact Questionnaire (FIQ)
- Meaningful change in Brief Pain Inventory average pain severity.
|
80 |
All |
18 Years and older (Adult, Senior) |
NCT01149018 |
THC-FMS-HMO-CTIL |
|
June 2010 |
July 2012 |
October 2012 |
June 23, 2010 |
June 23, 2010 |
|
- Pain Relief Unit, Hadassah Medical Organisation
Jerusalem, Israel
|
| 32 |
NCT02576912 |
Recruiting |
Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone |
|
- Drug: Active Delta-9-THC
- Drug: Active Pregnenolone
- Drug: Placebo
|
Interventional |
Phase 1 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Basic Science
|
- Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
- Clinician Administered Dissociative Symptoms Scale (CADSS)
- Visual Analog Scale (VAS)
- (and 2 more...)
|
19 |
All |
18 Years to 55 Years (Adult) |
NCT02576912 |
1501015242 |
THC-Preg |
February 2015 |
December 2017 |
December 2017 |
October 15, 2015 |
June 23, 2017 |
|
- Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine
West Haven, Connecticut, United States
|
| 33 |
NCT00842985 |
Completed
Has Results |
Dronabinol Interactions With Cognitive Enhancing Drug in Humans |
|
|
Interventional |
Early Phase 1 |
- Yale University
- VA Office of Research and Development
- National Institute on Drug Abuse (NIDA)
|
Other / U.S. Fed / NIH |
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- CANTAB:CAmbridge Neuropsychological Test Automated Battery RVIP: Rapid Visual Information Processing
|
53 |
All |
18 Years to 55 Years (Adult) |
NCT00842985 |
0702002357
MIRECC 00000000
P50DA009241 |
|
September 2008 |
October 2009 |
October 2009 |
February 12, 2009 |
May 30, 2017 |
December 17, 2012 |
- Department of Veterans Affairs Hospital
West Haven, Connecticut, United States
|
| 34 |
NCT00153192 |
Completed |
Study to Evaluate the Efficacy of Dronabinol (Marinol) as Add-On Therapy for Patients on Opioids for Chronic Pain |
|
- Drug: Marinol (dronabinol)
|
Interventional |
Phase 2
Phase 3 |
- Brigham and Women's Hospital
- Solvay Pharmaceuticals
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Single-Dose Phase
- - Total pain relief (TOTPAR) at 8 hours
- Multi-Dose Phase
- (and 18 more...)
|
30 |
All |
Child, Adult, Senior |
NCT00153192 |
2001-P-000474
BN7894973 |
|
April 2001 |
April 2006 |
April 2006 |
September 12, 2005 |
April 26, 2013 |
|
- Brigham and Women's Hospital
Boston, Massachusetts, United States
|
| 35 |
NCT00490269 |
Completed
Has Results |
Ph1 Marinol Interaction Study - Part 2 - 1 |
|
- Drug: Placebo
- Drug: Dronabinol
|
Interventional |
Phase 1 |
- National Institute on Drug Abuse (NIDA)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
|
- Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects.
|
12 |
All |
18 Years to 45 Years (Adult) |
NCT00490269 |
NIDA-CPU-0013-1 |
|
October 2006 |
December 2007 |
December 2007 |
June 22, 2007 |
January 12, 2017 |
April 8, 2013 |
- Uniformed Services University of Health Science
Bethesda, Maryland, United States
|
| 36 |
NCT01755091 |
Completed
Has Results |
Safety and Efficacy Study of Dronabinol to Treat Obstructive Sleep Apnea |
|
- Drug: Dronabinol
- Drug: Placebo (for Dronabinol)
|
Interventional |
Phase 2 |
- University of Illinois at Chicago
- Northwestern University
- University of Chicago
- Hektoen Institute for Medical Research
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Apnea/Hypopnea Index (AHI)
- Change in Epworth Sleepiness Scale (ESS)
- Change in Sleep Latency: Maintenance of Wakefulness Test (MWT)
- (and 3 more...)
|
75 |
All |
21 Years to 64 Years (Adult) |
NCT01755091 |
UM1HL112856 2011-06400
UM1HL112856 |
PACE |
February 2013 |
June 2016 |
December 31, 2016 |
December 21, 2012 |
December 22, 2017 |
December 22, 2017 |
- Northwestern University
Chicago, Illinois, United States - University of Illinois at Chicago
Chicago, Illinois, United States
|
| 37 |
NCT03206463 |
Not yet recruiting |
Cognitive and Psychophysiological Effects of Delta-9-Tetrahydrocannabinol in Bipolar Disorder |
- Delta-9-Tetrahydroncannabinol
- Bipolar Disorder
- Healthy Controls
|
- Drug: 4 mg Delta-9-THC
- Drug: Placebo
- Drug: 2 mg Delta-9-THC
|
Interventional |
Phase 1 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Basic Science
|
- Change in Verbal memory
- Change in Executive functioning
- Attention
- (and 5 more...)
|
40 |
All |
18 Years to 55 Years (Adult) |
NCT03206463 |
2000020272 |
THC-BD |
July 2017 |
July 2019 |
July 2019 |
July 2, 2017 |
July 2, 2017 |
|
- Biological Studies Unit, VA Connecticut Healthcare System
West Haven, Connecticut, United States
|
| 38 |
NCT02492074 |
Not yet recruiting |
Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids - a PET Study |
- Healthy Volunteers
- Modeling Psychosis
|
- Drug: Delta-9-tetrahydrocannabinol
- Drug: Cannabidiol
- Drug: Placebo
|
Interventional |
Phase 1 |
- Central Institute of Mental Health, Mannheim
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Basic Science
|
- Change in Positive and Negative Syndrome Scale (total score, PANSS T) from baseline to post drug intake of both on induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal processing, and D2-receptor availability
- Change in PANSS subscores and clusters (baseline to post drug intake)
- Change in Digit Symbol Coding
- (and 11 more...)
|
60 |
Male |
18 Years to 45 Years (Adult) |
NCT02492074 |
GEI-TCP I |
|
April 2019 |
April 2020 |
May 2020 |
July 8, 2015 |
March 15, 2018 |
|
- Central Institute of Mental Health
Mannheim, BW, Germany
|
| 39 |
NCT00438139 |
Terminated |
Ph1 Marinol Interaction Study - Part 1 - 1 |
|
|
Interventional |
Phase 1 |
- National Institute on Drug Abuse (NIDA)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
6 |
All |
18 Years to 45 Years (Adult) |
NCT00438139 |
NIDA-CPU-0011-1 |
|
March 2007 |
March 2007 |
March 2007 |
February 21, 2007 |
January 16, 2017 |
|
- Uniformed Services University of Health Science
Bethesda, Maryland, United States
|
| 40 |
NCT01964404 |
Recruiting |
Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment? |
- Schizophrenia
- Dual Diagnosis
- Psychotic Disorder
- Cannabis Use Disorder
|
- Drug: Marijuana
- Drug: Dronabinol
- Drug: Placebo
|
Interventional |
Phase 1 |
- Alan Green
- Columbia University
- Harvard Medical School
- (and 5 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Basic Science
|
- Brain Reward Circuit Activation
- Resting State Connectivity
|
240 |
All |
18 Years to 55 Years (Adult) |
NCT01964404 |
1R01DA034699-01A1 |
|
July 2014 |
March 2020 |
April 2020 |
October 17, 2013 |
March 23, 2018 |
|
- Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States - University of Vermont
Burlington, Vermont, United States
|
| 41 |
NCT00743119 |
Completed
Has Results |
Comparison of the Analgesic Effects of Dronabinol and Smoked Marijuana in Daily Marijuana Smokers |
|
- Drug: Placebo capsules
- Drug: Inactive marijuana (0% THC)
- Drug: Low dose Dronabinol
- (and 3 more...)
|
Interventional |
Phase 2 |
- New York State Psychiatric Institute
- Research Foundation for Mental Hygiene, Inc.
- National Institute on Drug Abuse (NIDA)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Other
|
|
34 |
Female |
21 Years to 45 Years (Adult) |
NCT00743119 |
5603
5P50DA009236 |
|
June 2008 |
October 2009 |
May 2013 |
August 28, 2008 |
December 11, 2017 |
December 11, 2017 |
- New York State Psychiatric Institute
New York, New York, United States
|
| 42 |
NCT02335060 |
Active, not recruiting |
N-acetylcysteine Effects on Tetrahydrocannabinol |
|
- Drug: Delta-9-THC
- Drug: N-acetylcysteine
- Drug: Placebo
|
Interventional |
Phase 1 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Basic Science
|
- Positive and Negative Symptom Scale for Schizophrenia (PANSS)
- Clinician Administered Dissociative Symptoms Scale (CADSS)
- Visual Analog Scale (VAS)
- (and 3 more...)
|
36 |
All |
18 Years to 55 Years (Adult) |
NCT02335060 |
1402013406 |
|
March 2014 |
January 2019 |
January 2019 |
January 9, 2015 |
April 26, 2017 |
|
- VA Connecticut Healthcare System
West Haven, Connecticut, United States
|
| 43 |
NCT00642499 |
Completed |
Dronabinol Versus Placebo in Treatment and Prevention of Highly Active Anti-Retroviral Therapy (HAART)-Related Nausea and Vomiting |
- Highly Active Antiretroviral Therapy (HAART)-Related Nausea and Vomiting
- HIV Infections
|
- Drug: Dronabinol
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- The absence of nausea as indicated by a visual analog scale (VAS) score < 5 mm
- Number of episodes vomiting/retching
- Duration of nausea, vomiting/retching
- (and 2 more...)
|
103 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT00642499 |
S175.2.101 |
|
August 2003 |
April 2005 |
April 2005 |
March 25, 2008 |
April 2, 2008 |
|
- Site 911
Bakersfield, California, United States - Site 919
Fresno, California, United States - Site 924
Los Angeles, California, United States - (and 33 more...)
|
| 44 |
NCT00553059 |
Completed |
Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer |
- Chemotherapy-induced Nausea and Vomiting
- Unspecified Adult Solid Tumor, Protocol Specific
|
- Drug: dexamethasone
- Drug: dronabinol
- Drug: palonosetron hydrochloride
- Other: placebo
|
Interventional |
Phase 3 |
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
- Solvay Pharmaceuticals
|
Other / NIH / Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Supportive Care
|
- Number of Participants with Total protection
- Acute, Delayed and Overall Total Protection
- Complete response and Complete Protection for the acute, delayed, and overall periods
|
62 |
All |
18 Years and older (Adult, Senior) |
NCT00553059 |
2006-0841
MDA-2006-0841
CDR0000573510
NCI-2009-00637 |
|
May 2008 |
August 2014 |
|
November 5, 2007 |
September 5, 2014 |
|
- Cancer Research for the Ozarks
Springfield, Missouri, United States - CCOP - Greenville
Greenville, South Carolina, United States - University of Texas M.D. Anderson CCOP Research Base
Houston, Texas, United States - Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States
|
| 45 |
NCT01893424 |
Completed |
Bioequivalence Assessment of Oral Administration Vs. Oral Spray of a Cannabinoids (Tetrahydrocannabinol and Cannabidiol) |
|
- Drug: Sativex buccal spray
- Drug: CBD-THC-Piperine-PNL capsule
|
Interventional |
Phase 1 |
- Hadassah Medical Organization
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Pharmacokinetic parameters of THC and CBD
- exposure to the metabolites of the study drugs
|
12 |
Male |
18 Years to 45 Years (Adult) |
NCT01893424 |
0658-12-HMO-CTIL |
|
August 2013 |
January 2014 |
January 2015 |
July 9, 2013 |
March 24, 2016 |
|
- Hadassah medical organization
Jerusalem, Israel
|
| 46 |
NCT00760695 |
Completed |
Cannabinoid Receptor (CB1) Agonist Treatment in Severe Chronic Anorexia Nervosa |
|
- Drug: dronabinol
- Drug: placebo
|
Interventional |
Phase 3 |
- Odense University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Weight gain
- Eating Disorder Inventory (EDI) scale
- Motor and inner restlessness (estimated by accelerometry)
- Endocrine parameters
|
24 |
All |
18 Years and older (Adult, Senior) |
NCT00760695 |
033 |
|
October 2008 |
December 2011 |
December 2011 |
September 26, 2008 |
May 10, 2013 |
|
- Odense University Hospital
Odense, Denmark
|
| 47 |
NCT00316563 |
Completed |
Orexigenic Therapy With Delta-9-tetrahydrocannabinol in Advanced Cancer Patients With Chemosensory Abnormalities - a Pilot Study |
- Cancer
- Anorexia
- Taste Disorders
- Olfactory Disorders
|
- Drug: Marinol (Dronabinol)
- Other: Placebo
|
Interventional |
Phase 2 |
- Alberta Health Services
- University of Alberta
- AHS Cancer Control Alberta
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Total caloric intake
- self-perceived chemosensory ability
- palatable food intake
- (and 3 more...)
|
80 |
All |
18 Years and older (Adult, Senior) |
NCT00316563 |
PS-8-0008 |
|
August 2006 |
|
November 2009 |
April 21, 2006 |
February 9, 2010 |
|
- Cross Cancer Institute
Edmonton, Alberta, Canada - Royal Victoria Hospital
Montreal, Quebec, Canada
|
| 48 |
NCT00123201 |
Completed |
Study to Evaluate the Efficacy and Safety of Dronabinol Metered Dose Inhaler (MDI) in Acute Treatment of Migraine Headache |
- Migraine With Aura
- Migraine Without Aura
|
|
Interventional |
Phase 2 |
- Solvay Pharmaceuticals
- Nektar Therapeutics
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
|
|
All |
18 Years to 65 Years (Adult) |
NCT00123201 |
S175.2.103 |
|
September 2005 |
March 2007 |
March 2007 |
July 22, 2005 |
January 16, 2015 |
|
- Site 10
Huntsville, Alabama, United States - Site 8
Huntsville, Alabama, United States - Site 11
Tucson, Arizona, United States - (and 26 more...)
|
| 49 |
NCT02291536 |
Completed |
Processing of Salient Emotional Stimuli as a Function of Tetrahydrocannabinol (THC) and Cannabidiol (CBD) |
|
- Drug: tetrahydrocannabinol
- Drug: cannabidiol
- Other: placebo
|
Interventional |
Not Applicable |
- Central Institute of Mental Health, Mannheim
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Basic Science
|
- Correctly identified emotional pictures during the attentional blink period
- Reaction time to correctly identified emotional pictures during the attentional blink period
|
20 |
Male |
18 Years to 65 Years (Adult) |
NCT02291536 |
AB_THC_CBD |
AB_THC_CBD |
February 2014 |
December 2014 |
December 2014 |
November 14, 2014 |
January 16, 2015 |
|
- Central Institute of Mental Health
Mannheim, Germany
|
| 50 |
NCT00757822 |
Completed
Has Results |
Prevention of Postoperative Nausea and Vomiting (PONV) in Surgical Patients |
- Postoperative Nausea and Vomiting
|
- Drug: Dronabinol
- Drug: Ondansetron
|
Interventional |
Not Applicable |
- VA Office of Research and Development
|
U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Incidence of Postoperative Nausea and Vomiting
- Maximum Reported Post-Operative Nausea Scores on Visual Analog Scale (VAS) Scale
- Post-operative Nausea and Vomiting (PONV) Incidence 24-48 Hours Post Surgery
- (and 5 more...)
|
216 |
All |
18 Years and older (Adult, Senior) |
NCT00757822 |
CLIN-008-08S
0167_2008I |
PONV |
December 2009 |
December 2013 |
April 2015 |
September 23, 2008 |
May 13, 2016 |
May 13, 2016 |
- Central Arkansas Veterans Healthcare System-John L McClellan Memorial Veterans Hospital
Little Rock, Arkansas, United States
|
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