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Free Venlafaxine Treatment for Marijuana Addiction and Depression - 1 (VEN)

Primary Purpose

Depression, Marijuana Abuse

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Venlafaxine
Placebo
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring cannabis dependence, depression, treatment, venlafaxine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Venlafaxine

Placebo

Arm Description

Venlafaxine

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 16, 2005
Last Updated
April 22, 2019
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00131456
Brief Title
Free Venlafaxine Treatment for Marijuana Addiction and Depression - 1
Acronym
VEN
Official Title
Marijuana Addiction and Depression: Venlafaxine Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Marijuana Abuse
Keywords
cannabis dependence, depression, treatment, venlafaxine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Venlafaxine
Arm Type
Active Comparator
Arm Description
Venlafaxine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Venlafaxine
Other Intervention Name(s)
Effexor
Intervention Description
375mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Two Consecutive Weeks of Marijuana Abstinence
Description
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.
Time Frame
measured daily by self report for 12 weeks of the trial or length of study participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frances R Levin, M.D.
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.stars.columbia.edu
Description
Click here for the Substance Treatment and Research Service website

Learn more about this trial

Free Venlafaxine Treatment for Marijuana Addiction and Depression - 1

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