Effectiveness of Selegiline in Treating Marijuana Dependent Individuals - 1

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. Identifier: NCT00218517
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 12, 2017
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:
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 or disease Intervention/treatment Phase
Marijuana Abuse Drug: Selegiline hydrochloride Drug: Placebo Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Selegiline for Treatment of Cannabis Dependence
Study Start Date : March 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Marijuana addiction severity, Week 9
  2. Marijuana withdrawl symptoms, Week 9

Information from the National Library of Medicine

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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00218517

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

Responsible Party: Ivan Montoya, Program Official, NIDA Identifier: NCT00218517     History of Changes
Other Study ID Numbers: NIDA-19246-1
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: September 2016

Keywords provided by National Institute on Drug Abuse (NIDA):
cannabis use disorder

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs