NCT00167245已完成2 期
A Phase II, Randomized, Double-blind, Placebo-Controlled, Pilot Trial of Topiramate for Alcohol and Comorbid Cocaine Dependence
Kyle Kampman1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2004年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Percent of Participants Abstinent From Cocaine During Last 3 Weeks of 13 Week Trial
研究概览
简要总结
The primary purpose of this study is to test the effectiveness of topiramate for the treatment of combined alcohol and cocaine dependence. Topiramate is approved for the treatment of seizures. It has not been proven to be effective for the treatment of alcohol or cocaine dependence.
详细描述
The purpose of this study is to evaluate the efficacy of 300 mg/day of topiramate for the treatment of 200 treatment-seeking alcohol dependent outpatients with comorbid cocaine dependence in a double-blind, placebo-controlled 14-week trial, with a 6-month follow-up (3 months after completing medications).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and females, 18 years or older.
- •Meets DSM(Diagnostic and Statistical Manual)-IV criteria for current diagnoses of cocaine and alcohol dependence, determined by the SCID (Structured Clinical Interview for the DSM)-IV.
- •In the past 30 days, used no less than $200-worth of cocaine and meets the following drinking criteria as measured by the Timeline Followback (TLFB) (Sobell and Sobell, 1995) a. drank within 30 days of intake day, b. reports a minimum of 48 standard alcoholic drinks (avg. 12 drinks/wk) in a consecutive 30-day period over the 90-day period prior to starting intake (i.e., a minimum of 40% days drinking), and c. has 2 or more days of heavy drinking (defined as 5 or more drinks per day in males and 4 or more drinks per day in females) in this same pre-treatment period.
- •Two consecutive days of abstinence from cocaine and alcohol, determined by self-reports and confirmed by negative urine toxicology screens, a negative breathalyzer tests, and collateral report, a Clinical Institute Withdrawal Scale for Alcohol (CIWA-AR) (Sullivan et al., 1989) score below eight,. Subjects will be encouraged to achieve 3 consecutive days of abstinence, however, subjects who have achieved 2 consecutive days of abstinence will be included with the approval of the principal investigator. We anticipate that these subjects will comprise less than 5% of total enrolled subjects. Subjects will be given 2 additional weeks beyond the screening week to attain the appropriate period of cocaine and alcohol abstinence prior to randomization.
- •Lives a commutable distance from the Treatment Research Center (TRC) and agrees to attend all research visits including follow-up visits.
- •Speaks, understands, and prints in English.
排除标准
- •Abstinent from cocaine or alcohol for 30 consecutive days prior to signing consent form.
- •Meets DSM-IV criteria for dependence on any substance other than cocaine and alcohol (except nicotine and cannabis), determined by the SCID.
- •Needs treatment with any psychoactive medications including any anti-seizure medications (with the exception of Benadryl used sparingly, if necessary, for sleep).
- •Current use of phenytoin or any drug of similar class.
- •Meets DSM-IV criteria for schizophrenia or any psychotic disorder, or organic mental disorder. Subject meets current DSM-IV diagnosis of any other clinically significant psychiatric disorder that will interfere with study participation.
- •Has evidence of a history of significant hematological, pulmonary, endocrine, cardiovascular, renal or gastrointestinal disease.
- •Severe physical or medical illnesses such as AIDS, active hepatitis, significant hepatocellular injury as evidenced by elevated bilirubin levels (>1.3), or elevated levels (over 3.5x normal) of aspartate aminotransferase (AST), and serum glutamic-pyruvic transaminase (SGPT) after the required 3 days of abstinence, or severe renal disease, severe respiratory diseases or severe diarrhea with resulting metabolic acidosis, serum bicarbonate (< 20 milliequivalent (mEq)/L)
- •History of epilepsy or seizure disorder.
- •Use of an investigational medication in the 30 days prior to randomization.
- •History of nephrolithiasis (kidney stones).
- •History of hypersensitivity to topiramate.
- •Is female and tests positive on a pregnancy test, is contemplating pregnancy in the next 6 months, is nursing, or is not using an effective contraceptive method (if relevant). Acceptable methods of contraception include barrier methods (diaphragm or condom with spermicide, intrauterine progesterone contraceptive system, levonorgestrel implant, and medroxyprogesterone acetate contraceptive injection).
- •Current use of a carbonic anhydrase inhibitor.
- •A history of glaucoma
研究组 & 干预措施
Topiramate
Experimental
topiramate capsules dose titrated up to 300 mg daily
干预措施: Topiramate (Drug)
Placebo
Placebo Comparator
placebo capsules identical in appearance to the topiramate capsules
干预措施: placebo (Drug)
结局指标
主要结局
Percent of Participants Abstinent From Cocaine During Last 3 Weeks of 13 Week Trial
时间窗: Last 3 weeks of 13 week trial
Samples were analyzed for benzoylecgonine by fluorescent polarization assay. Samples containing equal to or greater than 300 ng/ml of benzoylecgonine were considered to be positive for cocaine.
Number of Heavy Drinking Days
时间窗: 13 weeks
Heavy drinking days, defined as more than 4 standard drinks for men and 3 standard drinks for women
次要结局
- Cocaine Withdrawal Symptoms Measured by Cocaine Selective Severity Assessment.(13 weeks)
- The Penn Alcohol Craving Scale(13 weeks)
研究者
Kyle Kampman
Sponsor-Investigator
University of Pennsylvania
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Topiramate in the Treatment of Posttraumatic Stress Disorder in CiviliansPost-Traumatic Stress DisorderNCT00208130Creighton University60
已完成
2 期
Topiramate for the Treatment of Methamphetamine Dependence - 1MethamphetamineNCT00345371National Institute on Drug Abuse (NIDA)140
已完成
3 期
Safety and Efficacy Study of Topiramate to Aid in Smoking CessationSmoking CessationNCT00280839Lindner Center of HOPE87
已完成
3 期
A Study of the Effectiveness and Safety of Topiramate for the Prevention of Migraine Attacks in ChildrenVascular HeadachesMigraineNCT00210535Johnson & Johnson Pharmaceutical Research & Development, L.L.C.110
终止
4 期
Topiramate: Long-Term Maintenance of Weight Loss Induced by Low-Calorie Diet in Obese SubjectsObesityNCT02040311University of Copenhagen701