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Effectiveness of Selegiline in Treating Marijuana Dependent Individuals - 1

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00218517
First received: September 16, 2005
Last updated: July 31, 2008
Last verified: July 2008
History of Changes
  Purpose

During the past 15 years, the demand for treatment for marijuana-related problems in the United States has increased nearly twofold. Selegiline is a medication currently used to treat nicotine dependence. The purpose of this study is to evaluate whether selegiline may be useful in treating individuals with marijuana dependence.


Condition Intervention Phase
Marijuana Abuse
 Drug: Selegiline hydrochloride
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Selegiline for Treatment of Cannabis Dependence

Resource links provided by NLM:

MedlinePlus related topics: Marijuana
U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Marijuana addiction severity, Week 9
  • Marijuana withdrawl symptoms, Week 9

Enrollment: 19
Study Start Date: March 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Selegiline hydrochloride
Daily oral selegiline, 5 mg po qd x 7 days, then 5 mg po bid for 7 weeks
Other Name: Selegiline, Selegiline hydrochloride, l-Deprenyl
Placebo Comparator: 2 Drug: Placebo
Matching placebo capsules using blue 00 capsules

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218517

Locations
United States, Connecticut
MRU
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Brent A Moore, Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Ivan Montoya, Program Official, NIDA
ClinicalTrials.gov Identifier: NCT00218517     History of Changes
Other Study ID Numbers: NIDA-19246-1, R21-19246-1, DPMC
Study First Received: September 16, 2005
Last Updated: July 31, 2008
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Mental Disorders
Selegiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses
Antiparkinson Agents
Anti-Dyskinesia Agents

ClinicalTrials.gov processed this record on May 21, 2013