Cognitive Enhancement as a Target for Cocaine Pharmacotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Urine Toxicology
研究概览
简要总结
Specific Aim #1: To determine if galantamine (8 or 16 mg/day) is more effective than placebo in reducing cocaine use as measured by cocaine urine results and self-report days of use.
Specific Aim # 2: To determine if galantamine (8 or 16 mg/day) is more effective than placebo in improving attention, assessed with the Rapid Visual Information Processing (RVIP) and the Simple Reaction Time (SRT) tests Specific Aim # 3: To determine if improvement in attention during the first four weeks of treatment will mediate galantamine's efficacy in reducing cocaine use.
详细描述
This will be a double-blind, placebo-controlled, randomized clinical trial. One hundred and twenty cocaine-dependent men and women will be randomized to one of three treatment groups: placebo (n=40), 8 mg/day (n=40), and 16 mg/day (n=40) of extended release (ER) galantamine. An urn randomization will be used to balance the groups for gender, severity of cocaine use (measured by days of cocaine use), baseline cognitive functioning [determined via the Shipley Institute of Living Scale (SILS)], and smoking status. Gender and severity of cocaine use have been shown to predict treatment responses in cocaine users (76). Similarly, balancing the treatment groups for baseline cognitive functioning, assessed with the SILS scores, will minimize the influence of baseline differences on cognitive outcomes (77, 78). Smoking status is also an important baseline variable, given galantamine's actions on nicotinic receptors and its potential efficacy for smoking cessation (65). The initial dose of galantamine will be 8 mg/day as a single dose, as recommended for clinical use. For those assigned to 16 mg/day, the dose of galantamine will be increased to 16 mg at the end of week 4. Treatment groups will remain on their full dosage through week 13. All participants will receive contingency management (CM) targeting treatment compliance. In three previous cocaine pharmacotherapy trials using bupropion, desipramine or levodopa, medication efficacy on cocaine use was evident only when medications were combined with CM, but not with standard care (79-81). These findings provide a strong rationale for using CM in our clinical trial.
Recruitment is continuing. This protocol was amended as of May 2014 to come to one dispensing visit and up too, two clinic visits. The payment has changed from gift cards to cash. This change should help increase the number of completers.
Currently there are 40 completers with 9 active and 6 in follow up phase. The follow up phase ended June 2016. Currently in analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Male and females, between the ages of 18 and 60
- •Are using cocaine more than once per week in the previous 30 days, provide a cocaine-positive urine specimen at screening, and fulfill criteria for current cocaine dependence according to DSM-IV
- •For women of child-bearing age, have a negative pregnancy test at screening, agree to adequate contraception to prevent pregnancy, and agree to have monthly pregnancy tests
- •Are fluent in English and have a 6th grade or higher reading level; AND
- •Can commit to at least 13 weeks of treatment and are willing to be randomized to treatment
排除标准
- •Meet DSM-IV psychiatric classifications for lifetime schizophrenia or bipolar disorder, or have a depressive or anxiety disorder with current use of a prescribed psychotropic medication that cannot be discontinued
- •Current DSM-IV diagnosis of drug or alcohol dependence (other than cocaine, or tobacco)
- •Demonstrate significant medical conditions, including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal deficit and cardiac rhythm disturbances or any other medical conditions that the study physician deems contraindicated for galantamine treatment
- •Use of other medications including:
- •drugs that slow heart rate (e.g., beta-blockers), which may increase the risk of bradycardia and atrioventricular (AV) block and
- •non-steroidal anti-inflammatory drugs (NSAIDs); increased potential for developing ulcers/active or occult gastrointestinal bleeding
- •Have a screening liver function test (AST or ALT) greater than 3 times normal; OR
- •Known allergy or adverse reaction to galantamine
研究组 & 干预措施
Sugar Pill
Sugar Pill will be compared with the active medication Galantamine
干预措施: Placebo (Drug)
Galantamine
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
干预措施: Galantamine (Drug)
结局指标
主要结局
Urine Toxicology
时间窗: 12 weeks
Presented are the average number of urine samples positive for cocaine over 12 weeks. This outcome was corrected from the protocol registration when the study data were entered.
次要结局
- Heart Rate(once a day for up to two days over 12 Weeks)
- Blood Pressure- Diastolic(2 times a week for 12 weeks)
- CANTAB RVIP Measure: RVP B(Baseline and 12 Weeks)
- CANTAB SST- SSRT(Baseline and 12 Weeks)
- CANTAB SST- Median Correct(Baseline and 12 Weeks)
- Stroop- Effect Drug Neutral Mean Correct(weeks 0, 4, 8, 12, 16, 24, 36)
- Blood Pressure- Systolic(2 times a week for 12 weeks)
- CANTAB RVIP Measure: RVP A(Baseline and 12 Weeks)
- Digit Span- LDSF(Baseline and 12 Weeks)
- Digit Span- DSF(Baseline and 12 Weeks)
- Digit Span- LDSB(Baseline and 12 Weeks)
- CANTAB RVIP Measure: RVP FALSE ALARM(Baseline and 12 Weeks)
- CANTAB SST- SD Correct(Baseline and 12 Weeks)
- Stroop- RT Correct Neutral(weeks 0, 4, 8, 12, 16, 24, 36)
- Stroop- RT Correct Drug(weeks 0, 4, 8, 12, 16, 24, 36)
- Digit Span- DSB(Baseline and 12 Weeks)