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Effectiveness of Selegiline in Treating Marijuana Dependent Individuals - 1

Selegiline for Treatment of Cannabis Dependence

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00218517
Enrollment
19
Registered
2005-09-22
Start date
2005-03-31
Completion date
2007-07-31
Last updated
2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Marijuana Abuse

Keywords

cannabis use disorder

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.

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.

Interventions

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

DRUGPlacebo

Matching placebo capsules using blue 00 capsules

Sponsors

National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Marijuana addiction severity, Week 9
Marijuana withdrawl symptoms, Week 9

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026