Free Venlafaxine Treatment for Marijuana Addiction and Depression - 1



Status:Completed
Conditions:Depression, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 60
Updated:11/30/2018
Start Date:March 2004
End Date:December 2010

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Marijuana Addiction and Depression: Venlafaxine Treatment

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

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.

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
We found this trial at
1
site
1051 Riverside Dr
New York, New York 10032
646-774-5000
New York State Psychiatric Institute The New York State Psychiatric Institute (NYSPI), established in 1895,...
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from
New York, NY
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