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OpenTrials
Completed

NCT Number: NCT00218517

Effectiveness of Selegiline in Treating Marijuana Dependent Individuals - 1

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MRU

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selegiline hydrochloride

Drug

Daily oral selegiline, 5 mg po qd x 7 days, then 5 mg po bid for 7 weeks

Other names: Selegiline, Selegiline hydrochloride, l-Deprenyl

Placebo

Drug

Matching placebo capsules using blue 00 capsules

Primary outcomes

  1. Marijuana addiction severity, Week 9

  2. Marijuana withdrawl symptoms, Week 9

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

Selegiline for Treatment of Cannabis Dependence

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 22, 2005
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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