Marijuana Addiction and Depression: Venlafaxine Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Two Consecutive Weeks of Marijuana Abstinence
研究概览
简要总结
The purpose of this study is to determine if Venlafaxine Extended Release (Ven-XR) is effective in treating individuals with marijuana addiction and depression.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
Venlafaxine
Venlafaxine
干预措施: Venlafaxine (Drug)
结局指标
主要结局
Two Consecutive Weeks of Marijuana Abstinence
时间窗: measured daily by self report for 12 weeks of the trial or length of study participation
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.
次要结局
未报告次要终点
研究者
Frances R Levin
Director of Substance Use Disorder
National Institute on Drug Abuse (NIDA)