Effectiveness Study of Dronabinol and BRENDA for the Treatment of Cannabis Withdrawal

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00480441
First received: May 30, 2007
Last updated: January 17, 2012
Last verified: January 2012
  Purpose

This treatment study is targeted specifically for those who want to stop using marijuana. We want to find out if patients who are dependent on marijuana and want to stop using are helped by a combination of the drug dronabinol and six sessions of individual therapy (BRENDA). Dronabinol is a pill form of the active ingredient in marijuana (THC). Currently, dronabinol is approved for the treatment of nausea in people receiving cancer chemotherapy and as an appetite stimulant in people with AIDS.

In some studies, dronabinol reduced the amount of psychological and physical discomfort experienced when people stopped using marijuana. One purpose of our study is to see if people who are on dronabinol have fewer problems with psychological and physical discomfort than those who are on a placebo.

In addition to treatment, this research trial will also be measuring the reactions of subjects to drug-related cues, and also to computer-presented tasks unrelated to drug use. We may examine whether the response to these cues/tasks either predicts treatment outcome, or is affected by your treatment. This information may also help us to understand the ways in which chronic drug use causes changes in our subjects' mental functioning and how those changes respond to treatment.

In addition to participation in the treatment research trial, some subjects may be asked to undergo a brain scan in an MRI. The purpose of the brain scan research project is to measure brain reactions with a non-invasive, non-radioactive imaging technique known as fMRI (functional magnetic resonance imaging) in marijuana subjects before and after treatment with the medication dronabinol or with an inactive substance (placebo).


Condition Intervention Phase
Marijuana Dependence
Drug: Dronabinol
Behavioral: BRENDA therapy
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Double-Blind Placebo-Controlled Trial of Dronabinol and BRENDA for the Treatment of Cannabis Withdrawal

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Cannabis dependent patients will be able to tolerate dronabinol. [ Time Frame: at every follow up visit, 3 times/wk initially then weekly for 6 weeks ] [ Designated as safety issue: Yes ]
  • Dronabinol will attenuate cannabis withdrawal. [ Time Frame: at every follow up visit, 3 times/wk initially then weekly for 6 weeks ] [ Designated as safety issue: No ]
  • The quantitative THC and self-report measurements will decrease over the time of study. [ Time Frame: at every follow up visit, 3 times/wk initially then weekly for 6 weeks ] [ Designated as safety issue: No ]
  • Cannabis dependent patients will complete neurocognitive assessments with dronabinol improving performance in certain spheres of function. [ Time Frame: every 2 weeks ] [ Designated as safety issue: No ]
  • Cannabis dependent patients will demonstrate physiological changes in response to cue-induced craving which will be attenuated by dronabinol treatment. [ Time Frame: at baseline and after 2 weeks of medications ] [ Designated as safety issue: No ]
  • Select group of cannabis dependent patients will complete fMRI scans with demonstrable dronabinol related changes in brain activation. [ Time Frame: at baseline and after 2weeks on medications ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Structural and perfusion brain differences will be correlated with performance on neurocognitive tasks [ Time Frame: at baseline and after 2 weeks of medications ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: August 2006
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Dronabinol+ BRENDA therapy
Drug: Dronabinol
10mg capsules taken 4 times daily for 2 weeks and then tapered over 1 week
Other Name: Marinol
Behavioral: BRENDA therapy
weekly therapy sessions for 6 weeks
Placebo Comparator: 2
Placebo+BRENDA therapy
Behavioral: BRENDA therapy
weekly therapy sessions for 6 weeks
Drug: Placebo
4 capsules daily for 2 weeks followed by a 1 week taper

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females, 18-55 years old
  2. Meets DSM-IV criteria for Cannabis Dependence
  3. History of chronic cannabis use of moderate intensity defined by 10 or more years of use with an average frequency of 2 or more joints/day on 5 or more days/week
  4. Live within a commutable distance of the Treatment Research Center
  5. Understand and sign the informed consent
  6. Voluntarily seeking treatment for cannabis dependence

Exclusion Criteria:

  1. Current DSM-IV diagnosis of any psychoactive substance dependence other than marijuana, or nicotine dependence
  2. Concomitant treatment with sedative hypnotics, opioid analgesics or other known CNS depressants at a dose and frequency that is unacceptable to the principal investigator
  3. Mandated to treatment based upon a legal decision or as a condition of employment
  4. Current severe psychiatric symptoms, e.g. psychosis, dementia, acute suicidal or homicidal ideation, mania or depression requiring antidepressant therapy, or which could make it unsafe for the patient to participate in the opinion of the primary investigators
  5. History of significant, unstable heart disease, including myocardial infarction, unstable angina, cardiac failure, second or third degree heart block, uncontrolled hypertension, syncope
  6. Known hypersensitivity to cannabinoids or sesame oil
  7. Any serious medical illness, which may require hospitalization during the study (i.e. sickle cell anemia, rheumatoid arthritis)
  8. Has any disease of the gastrointestinal system, liver or kidneys which could result in altered metabolism or excretion of the study medication (history of major gastrointestinal tract surgery, gastrectomy, gastrotomy, bowel resection, etc.) or history of chronic gastrointestinal disorders (ulcerative colitis, regional enteritis, or gastrointestinal bleeding)
  9. Female subjects who are pregnant or lactating, or female subjects of child bearing potential who are not using acceptable methods of birth control. Acceptable methods of birth control include:

    Barrier (diaphragm or condom) with spermicide, Intrauterine device, Levonorgestrel implant, Medroxyprogesterone acetate contraceptive injection, Oral contraceptives.

  10. Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits that are clinically unacceptable to the principal investigators. On EKG, 1st degree heart block, sinus tachycardia, left axis deviation, and nonspecific ST or T wave changes are allowed. Liver function tests (LFT's) <5 times ULN without symptoms of liver disease are acceptable after thorough medical review.

Additional Neuroimaging Exclusion Criteria:

Subjects who are selected for the clinical trial based on above inclusion and exclusion criteria will be screened further with the following exclusion criteria for possible participation in the fMRI imaging session:

  1. Participation in a clinical trial and receipt of investigational drug(s) other than this clinical trial during previous 60 days.
  2. History of serious head trauma or injury causing loss of consciousness that lasted more than 3 minutes.
  3. Presence of magnetically active prosthetics, plates, pins, broken needles, permanent retainer, bullets, etc. in subject's body (unless a radiologist confirms that its presence is unproblematic). An X-ray may be obtained to determine eligibility.
  4. Claustrophobia or other medical condition disabling subject from laying in the MRI for approximately 60 minutes
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480441

Locations
United States, Pennsylvania
Treatment Research Center at the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Charles O'Brien, M.D./Ph.D. Treatment Research Center at the University of Pennsylvania
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marina Goldman, M.D., University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00480441     History of Changes
Other Study ID Numbers: 5-P60-DA-005186-19, 5P60DA005186-19
Study First Received: May 30, 2007
Last Updated: January 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
Marijuana
Addiction
Substance Withdrawal Syndrome
Clinical Trial
Dronabinol
Behavioral Therapy
Adults
Neuroimaging
Neuropsychological Testing
Neurocognitive Testing
Behavioral Probes

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014