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Effectiveness of Selegiline in Treating Marijuana Dependent Individuals - 1

Primary Purpose

Marijuana Abuse

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Selegiline hydrochloride
Placebo
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marijuana Abuse focused on measuring cannabis use disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MRU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 16, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00218517
Brief Title
Effectiveness of Selegiline in Treating Marijuana Dependent Individuals - 1
Official Title
Selegiline for Treatment of Cannabis Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Abuse
Keywords
cannabis use disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Selegiline hydrochloride
Other Intervention Name(s)
Selegiline, Selegiline hydrochloride, l-Deprenyl
Intervention Description
Daily oral selegiline, 5 mg po qd x 7 days, then 5 mg po bid for 7 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo capsules using blue 00 capsules
Primary Outcome Measure Information:
Title
Marijuana addiction severity, Week 9
Title
Marijuana withdrawl symptoms, Week 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brent A Moore, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
MRU
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Selegiline in Treating Marijuana Dependent Individuals - 1

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