Medications Development for the Treatment of Cannabis Related Disorders (MTC)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01204723 |
Recruitment Status :
Completed
First Posted : September 17, 2010
Last Update Posted : June 1, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nicotine Withdrawal Marijuana Dependence Cannabis Dependence Nicotine Dependence Cannabis Abuse | Drug: Placebo Aprepitant Drug: Active Aprepitant | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 63 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | Medications Development for the Treatment of Cannabis Related Disorders |
Study Start Date : | August 2009 |
Actual Primary Completion Date : | January 2012 |
Actual Study Completion Date : | April 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Behavioral Condition 1
Nicotine patch (21 mg) plus placebo oral cannabis (0 mg; 3 times a day on days 2-4, given once on day 5)
|
Drug: Placebo Aprepitant
Placebo Aprepitant 0 mg once daily for 5 days Drug: Active Aprepitant Active Aprepitant 160 mg once daily for 5 days |
Experimental: Behavioral Condition 2
Placebo nicotine patch (0 mg) plus oral cannabis (10 mg, 3 times each day, days 2-4, day 5 given once)
|
Drug: Placebo Aprepitant
Placebo Aprepitant 0 mg once daily for 5 days Drug: Active Aprepitant Active Aprepitant 160 mg once daily for 5 days |
Experimental: Behavioral Condition 3
Placebo nicotine patch (0 mg) plus placebo oral cannabis (0 mg, 3 times each day days 2-4, day 5 given once)
|
Drug: Placebo Aprepitant
Placebo Aprepitant 0 mg once daily for 5 days Drug: Active Aprepitant Active Aprepitant 160 mg once daily for 5 days |
- withdrawal symptom severity, measured on a 0 (not at all) to 3 (severe) scale [ Time Frame: collected on each study day ]Subjective experience of withdrawal symptoms for cannabis, tobacco, and both (eg: Irritability, Sleep difficulty, Chills, Nervousness)
- "craving" measured using the Marijuana craving questionaire and the tobacco craving questionaire [ Time Frame: collected on each study day ]Subjective measures of craving for cannabis, tobacco, and both Questionaires are anchored with strongly disagree to strongly agree (1-7)
- reinforcing effects, as measured using the Multiple Choice Questionaire [ Time Frame: collected each day of study ]Reinforcement value of cannabis and tobacco as measured by preference for money over the administration of either drug; questionaire has 70 questions and money value vs. drug ranges from 25 cents to 25 dollars 1-70.
- sleep quality [ Time Frame: collected on each study day ]A VAS sleep questionnaire will be used each morning to assess daily sleep quality.
- Neurocognitive Function [ Time Frame: collected on days 1-4 of the study ]The purpose of examining the neurocognitive function of our participants on days 1-4 is to examine the safety of the co-administration of aprepitant at 160 mg/day with oral THC (dronabinol 10 mg) on brain function. Tasks used are the DSST - The Digit Symbol Substitution Test measures the learning of integrating visual and motor skills, and the SRTT- The Simple reaction Time Task is a well validated computerized test for assessing the effects of psychoactive drugs on performance.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: each day of study ]Blood pressure, pulse, and a Systematic Assessment For Treatment Emergent Events (SAFTEE) are collected daily. Electrocardiograms (EKGs) are collected at baseline and discharge.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Must meet DSM-IV/ICD-10 criteria for cannabis abuse or dependence
- Must be non-treatment seeking individuals
- Participant does not meet DSM-IV criteria for any current (i.e., criteria met at any point in the past 30 days) dependence on a substance other than alcohol, nicotine, caffeine, or marijuana or physiological dependence on alcohol requiring medical detoxification.
- No subjects who have trouble reading the English language or visual or hearing problems that may interfere with the collection of data
- Not currently taking other medications (with the exception of oral contraceptives) that would preclude safe participation in this study
- Must test negative for pregnancy prior to inclusion
- females using birth control pills must agree to use a condom during intercourse for 1 month after participation in study because the study medication will decrease the effectiveness of the birth control pill rendering it ineffective
- Should be in general good health
- No evidence of recent use of other illicit drugs on a urine toxicity screen prior to admission
Exclusion Criteria:
- Major current (within last 90 days) Axis I psychopathology (e.g., major depressive disorder, bipolar disorder, schizophrenia)
- Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension, cancer, epilepsy, kidney disease)
- Current, repeated illicit drug use (other than marijuana)
- Subject is breastfeeding or pregnant
- Concurrent therapy with drugs known to inhibit CYP3A4 activity
- Request for drug treatment
- Current parole or probation
- Recent history of significant violent or suicide behavior
- Allergic to sesame oil

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204723
United States, Virginia | |
Clinical Pharmacological Research Unit (CPRU), University of Virginia School of Medicine | |
Charlottesville, Virginia, United States, 22903 | |
University of Virginia Center for Addiction Education and Treatment (UVA CARE) | |
Charlottesville, Virginia, United States, 22908 |
Principal Investigator: | Heather M Haughey, Ph.D. | University of Virginia School of Medicine, Dept. Psychiatry and Neurobehavioral Sciences |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Virginia |
ClinicalTrials.gov Identifier: | NCT01204723 History of Changes |
Other Study ID Numbers: |
14392 R01DA027131 ( U.S. NIH Grant/Contract ) |
First Posted: | September 17, 2010 Key Record Dates |
Last Update Posted: | June 1, 2012 |
Last Verified: | May 2012 |
Keywords provided by University of Virginia:
Marijuana Abuse cannabis Nicotine Dependence Nicotine Withdrawal neurokinin Receptor NK1 Receptor antagonist Substance P Recurrence Substance Withdrawal Syndrome Substance-Related Disorders Disorders of Environmental Origin Mental Disorders |
Disease Attributes Pathologic Processes Tetrahydrocannabinol Therapeutic Uses Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Narcotic Antagonists |
Additional relevant MeSH terms:
Marijuana Abuse Tobacco Use Disorder Substance Withdrawal Syndrome Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Nicotine Aprepitant Fosaprepitant Peripheral Nervous System Agents Analgesics Molecular Mechanisms of Pharmacological Action |
Ganglionic Stimulants Autonomic Agents Physiological Effects of Drugs Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Sensory System Agents Antiemetics Gastrointestinal Agents Neurokinin-1 Receptor Antagonists |