Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse With Methadone Maintained Individuals
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Cocaine Use
研究概览
简要总结
We are testing to see if Galantamine, a learning enhancing medication, will help methadone maintained cocaine abusers with their learning and memory specific to CBT using an innovative CBT computer program.
详细描述
We are proposing a randomized double blind clinical trial of galantamine and our innovative computer-assisted version of CBT, alone and in combination, to improve treatment outcome and cognitive functioning among cocaine users. The proposed study will be the first to evaluate a cognitive enhancing medication as a means of enhancing the effects of an extremely promising empirically validated behavioral therapy for addiction, and hence bridge cognitive neuroscience and behavioral therapies development.
The aim is to conduct a 12 week randomized placebo controlled trial, using a 2x2 factorial model, that will evaluate the efficacy of adding computer assisted training in CBT ("CBT4CBT") and galantamine to standard treatment for 160 cocaine abusing or dependent methadone-maintained individuals. Participants will be randomized to (1) standard treatment (TAU) plus placebo, (2) TAU plus galantamine, (3) TAU plus CBT4CBT plus placebo, or (4) TAU plus CBT4CBT plus galantamine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between ages of 18 and 50
- •Enrolled in RNP methadone program and stable on methadone for at least 3 weeks
- •Current cocaine abuse or dependence according to DSM-IV criteria
- •No current medical problems and normal ECG
- •If female, not currently pregnant or breast feeding and using reliable birth control
- •Fluent in English and have at least a 6th grade reading level
- •Can commit to 12 weeks of treatment and are willing to be randomized
排除标准
- •Current major psychiatric illness including mood, psychotic or anxiety disorder
- •History of major medical illnesses including asthma, chronic obstructive lung disease, gastrointestinal ulcer, hepatic or renal impairment, cardiac rhythm disturbances
- •Use of medications including beta blockers and NASAIDs
- •Known allergy to Galantamine
研究组 & 干预措施
TAU Plus Galantamine
Standard treatment plus Galantamine. In this study, we will use 8 mg galantamine extended release (ER). Galantamine ER is used once daily. The recommended initial dose is 8 mg/day and the maintenance dose is 16-24 mg/day.
干预措施: Galantamine (Drug)
TAU plus Computer Assisted Cognitive Behavioral Therapy (CBT)
TAU plus computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
干预措施: Computer Assisted Cognitive Behavioral Therapy (CBT) (Behavioral)
TAU plus CBT plus galantamine
Standard treatment, plus computer assisted cognitive behavioral therapy, plus galantamine.
干预措施: Galantamine (Drug)
TAU plus CBT plus galantamine
Standard treatment, plus computer assisted cognitive behavioral therapy, plus galantamine.
干预措施: Computer Assisted Cognitive Behavioral Therapy (CBT) (Behavioral)
结局指标
主要结局
Cocaine Use
时间窗: 12 weeks
Reduction in cocaine use, operationalized as the frequency of cocaine use by month using timeline followback.
Cocaine Abstinence
时间窗: 12 weeks
operationalized by percentage of drug-free urine specimens submitted (We will use the Branan ToxCup Drug Screen Cup onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepine, and opioids) at 12 Weeks
次要结局
- Cognitive Function(12 weeks)