Effectiveness of Selegiline in Treating Marijuana Dependent Individuals - 1

Marijuana Abuse Clinical Trial

Official title:

Selegiline for Treatment of Cannabis Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218517
• Other study ID #: NIDA-19246-1
• Secondary ID: R21-19246-1DPMC
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2005
• Last updated: January 11, 2017
• Start date: March 2005
• Est. completion date: July 2007

Study information

• Verified date: September 2016
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Marijuana Abuse

Intervention

Drug:
• Selegiline hydrochloride
Daily oral selegiline, 5 mg po qd x 7 days, then 5 mg po bid for 7 weeks
• Placebo
Matching placebo capsules using blue 00 capsules

Locations

Country	Name	City	State
United States	MRU	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marijuana addiction severity, Week 9
Primary	Marijuana withdrawl symptoms, Week 9