Phase 2
Completed N=103
Free Venlafaxine Treatment for Marijuana Addiction and Depression - 1
Depression · Marijuana Abuse
Source: ClinicalTrials.gov NCT00131456 ↗
Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcomePrimary: Two Consecutive Weeks of Marijuana Abstinence — 19; 6 participants — p=<0.01
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Two Consecutive Weeks of Marijuana Abstinence |
19; 6 | <0.01 sig |
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
Data sourced from ClinicalTrials.gov (NCT00131456). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.