Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT00131456
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00131456
Study Brief:
Protocol Section:
NCT00131456