- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00218517
Effectiveness of Selegiline in Treating Marijuana Dependent Individuals - 1
Selegiline for Treatment of Cannabis Dependence
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Behavioral therapy paired with drug therapy might be a more effective treatment approach to marijuana dependence than behavioral therapy alone. Selegiline is a monoamine oxidase-B inhibitor. It increases dopamine activity in parts of the brain that are involved in dependence on addictive drugs such as nicotine, cocaine, and marijuana. Selegiline has been effective in treating nicotine dependence, but has not yet been studied in treating marijuana dependent individuals. The purpose of this study is to evaluate the effectiveness of selegiline in treating marijuana dependent individuals. Specifically, this study will determine whether selegiline reduces marijuana craving and withdrawal symptoms, thus leading to reduction or abstinence in marijuana use.
Participants in this 9-week, double-blind, placebo-controlled study will be randomly assigned to receive either selegiline (10 mg/day in two 5 mg pills) or placebo. Study visits will occur twice each week. At each study visit, participants will complete self-reports and urine toxicology tests. Throughout the study, participants will receive weekly individual counseling. The counseling sessions will last 15 minutes. Reduction in marijuana use as well as the number of weeks of consecutive marijuana abstinence will be evaluated.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06519
- MRU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Meets DSM-IV criteria for current marijuana dependence
- Positive urine toxicology test for marijuana
- Reports current marijuana use
- Weighs at least 100 lbs
- Women of childbearing age will be included provided they agree to use adequate contraception
Exclusion Criteria:
- Meets dependence or abuse criteria for alcohol
- Meets dependence criteria for illicit substances other than marijuana
- Serious medical disorders (such as unstable angina or liver failure), that may make participation in the trial unsafe
- Pregnant
- Currently diagnosed with a psychotic disorder
- Currently suicidal or pose a homicidal risk
- Currently taking over-the-counter (e.g., pseudoephedrine) or prescription (e.g., methylphenidate) sympathomimetic agents, antidepressant agents (e.g., tricyclic antidepressants, serotonin reuptake inhibitors, bupropion, other monoamine oxidase inhibitors), or meperidine (Demerol)
- Unable to understand English
- Known hypersensitivity to selegiline hydrochloride
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Daily oral selegiline, 5 mg po qd x 7 days, then 5 mg po bid for 7 weeks
Other Names:
|
Placebo Comparator: 2
|
Matching placebo capsules using blue 00 capsules
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Marijuana addiction severity, Week 9
|
Marijuana withdrawl symptoms, Week 9
|
Collaborators and Investigators
Investigators
- Principal Investigator: Brent A Moore, Ph.D., Yale University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Marijuana Abuse
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Neuroprotective Agents
- Protective Agents
- Psychotropic Drugs
- Antidepressive Agents
- Monoamine Oxidase Inhibitors
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Selegiline
Other Study ID Numbers
- NIDA-19246-1
- DPMC (Other Identifier: NIDA)
- R21-19246-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Marijuana Abuse
-
Dartmouth-Hitchcock Medical CenterCompletedMarijuana Abuse and DependenceUnited States
-
York UniversityUniversity of ManitobaCompletedMarijuana Use | Marijuana DependenceCanada
-
Brown UniversityCompleted
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA); Research Foundation for Mental Hygiene...CompletedMarijuana SmokingUnited States
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)Completed
-
State University of New York at BuffaloCompleted
-
National Institute on Drug Abuse (NIDA)Completed
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA); Research Foundation for Mental Hygiene...Completed
-
Yale UniversityNational Institute on Drug Abuse (NIDA); Hartford Hospital; National Highway...Active, not recruiting
Clinical Trials on Selegiline hydrochloride
-
National Institute of Allergy and Infectious Diseases...National Institute of Neurological Disorders and Stroke (NINDS); Neurologic...CompletedHIV Infections | Cognition DisordersUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedHIV Infections | Cognitive DisordersUnited States
-
Ludwig-Maximilians - University of MunichCompletedMénière's DiseaseGermany
-
Somerset PharmaceuticalsCompleted
-
Somerset PharmaceuticalsCompleted
-
The Dana FoundationCompletedHIV Infections | Cognitive DisordersUnited States
-
Parkinson's Disease and Movement Disorder Center...Bausch Health Americas, Inc.CompletedParkinson's DiseaseUnited States
-
Mood and Anxiety Research, IncCompletedBorderline Personality DisorderUnited States
-
New York State Psychiatric InstituteTerminated