Free Venlafaxine Treatment for Marijuana Addiction and Depression - 1

NCT00131456 | Completed Phase 2 Results DMC

• 2 other identifiers: #4695R01DA015451
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if Venlafaxine Extended Release (Ven-XR) is effective in treating individuals with marijuana addiction and depression.

Conditions

Depression; Marijuana Abuse

Keywords

cannabis dependence; depression; treatment; venlafaxine

Outcome Measures

Primary Outcomes (1)

• Two Consecutive Weeks of Marijuana Abstinence

  The primary outcome measure for marijuana use was a dichotomous abstinence response,defined as at least two consecutive urine-confirmed abstinent weeks. Each week during the study, subjects were scored as urine-confirmed abstinent if both self-reported marijuana use for that week was negative, according to the quantitative substance use daily inventory (Timeline FollowBack), and all urines collected for that week were negative for THC. Patients who achieved the two consecutive abstinent weeks were classified as abstinent whether or not they subsequently dropped out of the study. Patients who dropped out of the study without achieving two continuous weeks of abstinence were classified as not abstinent.

  measured daily by self report for 12 weeks of the trial or length of study participation

Study Arms (2)

Venlafaxine

ACTIVE COMPARATOR

Venlafaxine

Drug: Venlafaxine

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Venlafaxine DRUG

375mg/day

Also known as: Effexor

Venlafaxine

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Meets criteria for current marijuana addiction and reports marijuana as primary drug of abuse
• Currently meets criteria for major depression or dysthymic disorder and receive a score of greater than or equal to 12 on the Hamilton Depression Inventory
• Clinically depressed for at least 3 months during a period of active marijuana use
• Women of child-bearing age will be included provided that they are not pregnant, based on the results of a blood pregnancy done at the time of screening and agree to use a method of contraception with proven efficacy and not to become pregnant during the study. To confirm this, blood pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study. If a woman becomes pregnant, the study medication will be discontinued.

You may not qualify if:

• Meets criteria for past manic or psychotic disorder, unless substance-related
• History of a seizure disorder
• Individuals with chronic organic mental syndrome
• Any significant risk for suicide based on current assessment and history of attempts
• History of allergic reaction to either Venlafaxine or Ven-XR
• Unstable physical disorders that might make participation hazardous, such as uncontrolled hypertension and tachycardia (SBP\>150, DBP \>90, or a sitting quietly HR\>100), acute hepatitis (patients with chronic mildly elevated transaminase levels (\<2x upper limit of normal are acceptable) or unstable diabetes
• History of failure to respond to a previous adequate trial of Venlafaxine of at least 300 mg. for at least a 6-week period
• Physical dependence on any other drugs (excluding nicotine) that would require medical detoxification
• Currently being prescribed psychotropic medication by another physician (in the last 3 weeks), except for acute treatment of insomnia.
• Pregnant or breast-feeding

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Links

• Click here for the Substance Treatment and Research Service website

MeSH Terms

Conditions

Depression; Marijuana Abuse

Interventions

Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Limitations and Caveats

This was an outpatient study and excluded patients with very severe depression. Thus we cannot generalize the findings to individuals with more severe depressive symptoms. The study length was relatively brief.

Results Point of Contact

• Title: Dr. Frances R. Levin
• Organization: Columbia University

frl2@columbia.edu

212-543-5896

Study Officials

• Frances R Levin, M.D.

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Substance Use Disorder

Study Record Dates

• First Submitted: August 16, 2005
• First Posted: August 18, 2005
• Study Start: March 1, 2004
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 24, 2019
• Results First Posted: June 4, 2013

Record last verified: 2019-04

Locations

US (1)