NCT00218517

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

January 12, 2017

Status Verified

September 1, 2016

Enrollment Period

2.3 years

First QC Date

September 16, 2005

Last Update Submit

January 11, 2017

Conditions

Keywords

cannabis use disorder

Outcome Measures

Primary Outcomes (2)

  • Marijuana addiction severity, Week 9

  • Marijuana withdrawl symptoms, Week 9

Study Arms (2)

1

EXPERIMENTAL
Drug: Selegiline hydrochloride

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

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

Also known as: Selegiline, Selegiline hydrochloride, l-Deprenyl
1

Matching placebo capsules using blue 00 capsules

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MRU

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Selegiline

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Brent A Moore, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

March 1, 2005

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

January 12, 2017

Record last verified: 2016-09

Locations