Free Venlafaxine Treatment for Marijuana Addiction and Depression - 1

Depression Clinical Trial

— VEN  

Official title:

Marijuana Addiction and Depression: Venlafaxine Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00131456
• Other study ID #: #4695
• Secondary ID: R01DA015451
• Status: Completed
• Phase: Phase 2
• Start date: March 2004
• Est. completion date: December 2010

Study information

• Verified date: April 2019
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Given that depression and marijuana addiction often occur together, medications to treat individuals diagnosed with both conditions may be effective. The purpose of this study is to determine the effectiveness of Ven-XR in treating individuals diagnosed with depression and marijuana addiction.

During this twelve-week, double-blind, placebo-controlled study, study visits will occur twice each week. During study visits, participants will receive either placebo or medication and provide a urine sample for drug screening. Blood tests will be collected each month and women must take pregnancy tests each month. Throughout the study, all participants will receive individualized psychotherapy sessions. At each study visit, participants will be given $5 to cover transportation costs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Marijuana Abuse

Intervention

Drug:
• Venlafaxine
375mg/day
• Placebo
Placebo

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Click here for the Substance Treatment and Research Service website