Treatment for Cannabis Withdrawal and Dependence
关键词
抽象
描述
This study will be a Phase II, single-site, 8-week, randomized, double-blind, placebo-controlled, parallel group comparison of aprepitant (125 mg/d) or placebo. Subjects will be 100 outpatients seeking treatment for current cannabis dependence with no clinically significant medical or psychiatric disorders (including substance use disorders or a positive drug screen for substances other than cannabis or nicotine). All subjects will receive weekly manual-guided abstinence-oriented counseling to facilitate showing a drug effect above and beyond available therapies (Weeks 0-8). Research assessments of marijuana use and withdrawal and drug safety and tolerability will occur weekly through the treatment phase of the 8-week study. Post treatment follow-up assessments will occur at Weeks 9 and 12. Neuropsychological testing will occur at Weeks 0 and 4 and 8.
Specific Aim 1: To evaluate the relative efficacy of aprepitant 125 mg/d vs. placebo for reducing cannabis withdrawal symptoms in cannabis dependent outpatients, including anxiety, mood, craving and sleep symptoms.
Specific Aim 2: To evaluate the relative efficacy of aprepitant 125 mg/d vs. placebo for reducing marijuana use in cannabis dependent outpatients.
Specific Aim 3: To evaluate the relative efficacy of aprepitant 125 mg/d vs. placebo for reducing cannabis related impairments in executive functioning in cannabis dependent outpatients.
日期
| 最后验证: | 02/28/2017 |
| 首次提交: | 06/02/2011 |
| 提交的预估入学人数: | 06/03/2012 |
| 首次发布: | 06/04/2012 |
| 上次提交的更新: | 03/28/2017 |
| 最近更新发布: | 04/30/2017 |
| 首次提交结果的日期: | 02/05/2017 |
| 首次提交质量检查结果的日期: | 02/05/2017 |
| 首次发布结果的日期: | 03/26/2017 |
| 实际学习开始日期: | 04/30/2011 |
| 预计主要完成日期: | 09/30/2015 |
| 预计完成日期: | 09/30/2015 |
状况或疾病
干预/治疗
Drug: Active Drug
Drug: Placebo pill
Behavioral: Manual-guided behavioral counseling
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Active Drug 125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling. | Drug: Active Drug 125mg/day for 8 weeks |
| Placebo Comparator: Placebo pill Placebo pill daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling. | Drug: Placebo pill 125mg/d placebo pill for 8 weeks |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Males or females from 18-70 years of age - Meets DSM IV criteria for current cannabis dependence - Seeking research-based outpatient treatment for cannabis dependence that involves daily oral medication - Smoked MJ daily at least 25 days per month during the 90 days prior to randomization - Current cannabis use verified by a positive urine test > 50 ng/ml - At least a 2-year history of regular MJ use - Willing and able to give informed consent Exclusion Criteria: - Abstinent from cannabis more than 2 days at the time of randomization - Currently meets DSM IV criteria for dependence on substances, or has urine drug screen positive for substances, other than cannabis or nicotine - Meets DSM IV criteria for a major AXIS I disorder other than cannabis and nicotine dependence, - Active suicidal ideation - Significant medical disorders that will increase potential risk or interfere with study participation, - Females who are pregnant, nursing or who are sexually active with child-bearing potential and refuse to use a double-barrier method of birth control during the study and for up to 4 weeks after study termination - Ongoing treatment with medications that may affect study outcomes, - Use of CYP3A4 strong inhibitors (e.g., ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir) and CYP3A4 moderate inhibitors (e.g., diltiazem) within the 2 week period prior the study drug administration or within 5 half-lives of the respective medication, whichever is longer, until study conclusion. - Consumption of grapefruit or grapefruit products from at least 2 weeks prior to study drug administration until study conclusion. - Ongoing treatment with medications that are primarily metabolized by CYP3A4 and may have increased plasma concentrations when co-administered with aprepitant, such as pimozide, terfenadine, astemizole or cisapride or corticosteroids, as well as benzodiazepines including midazolam, alprazolam, and triazolam. - Ongoing treatment with medications that are primarily metabolized by CYP2C9 (e.g., warfarin, tolbutamide). - Use of drugs (e.g., rifampin, carbamazepine, phenytoin) or herbal supplements (e.g., St John's wort) that induce CYP3A4 activity and may result in reduced plasma concentrations of aprepitant and decreased efficacy of aprepitant. - Inability to understand and/or comply with the provisions of the protocol and consent form. |
结果
主要结果指标
1. Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8 [Week 0 and Week 8]
