NCT00368290已完成2 期
Modafinil Treatment for Cocaine Dependence and HIV-High Risk Behavior
Kyle Kampman0 个研究点目标入组 94 人开始时间: 2006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
- 94
- 主要终点
- Percent of Participants Reporting no Cocaine Craving
研究概览
简要总结
The purpose of study is to determine if modafinil promotes cocaine abstinence and reduces high risk behavior in cocaine dependent subjects.
详细描述
The purpose of study is to determine if modafinil promotes cocaine abstinence and reduces HRB in cocaine dependent subjects. Modafinil (300 mg/day) or placebo will be administered in an 8-week double-blind trial to patients meeting diagnostic criteria for cocaine dependence in conjunction with Cognitive Behavioral Therapy (CBT).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 60 years;
- •Current DSM-IV diagnosis of cocaine dependence;
- •Using cocaine at least 8 days in a consecutive 30 day period over the 60 day period immediately preceding study entry (If subject was receiving inpatient substance abuse treatment within 30 days prior to screening, subject must have been using cocaine at least 8 days in a consecutive 30 day period over the 60 day period immediately preceding admission to inpatient treatment); 4.)Having a negative urine toxicology (BE) test during screening (no less than 5 days prior to randomization) and a negative urine toxicology (BE) test on the day of randomization. Repeat testing allowed until required negative BE results are obtained;
- •Able to provide written informed consent and to comply with all study procedures;
- •Women must be surgically sterile, at least two years postmenopausal, or, if of childbearing potential, be using a medically accepted method of birth control and agree to continue use of this method for at least 30 days after the last dose of study drug (i.e. barrier method with spermicide, steroidal contraceptive [oral and implanted, including Depo-Provera, contraceptives must be used in conjunction with a barrier method], or intrauterine device [IUD]).
排除标准
- •Currently dependent on any substance other than cocaine or nicotine;
- •Current Neurological or psychiatric disorders, such as psychosis, bipolar illness, organic brain disease, dementia, or any diseases that require psychotropic medications;
- •Serious medical illnesses, including but not limited to; uncontrolled hypertension, significant heart disease (including a history of myocardial infarction, angina, mitral valve prolapse, left ventricular hypertrophy, palpitations, and arrhythmia), hepatic disease, renal disease, or any serious, potentially life-threatening or progressive medical illness that may compromise patient safety or study conduct;
- •Received a drug with known potential for toxicity to a major organ system within the month prior to entering treatment including, but not limited to: chemotherapeutic agents for neoplastic disease (i.e. methotrexate, vincristine, vinblastine, fluorouracil), agents used for parasitic infections, isoniazid, chlorambucil, dactinomycin, chloramphenicol, immunosuppressive and cytotoxic agents (i.e. cyclosporine, tacrolimus), indomethacin, protease inhibitors, amphotericin B, cephalosporins, aminoglycosides, interferon, and sulfonamides;
- •Clinically significant abnormal laboratory values (see Appendix A);
- •Has any disease of the gastrointestinal system, liver, or kidneys which could result in altered metabolism or excretion of the study medication (history of major gastrointestinal tract surgery, gastrectomy, gastrostomy, bowel resection, etc.) or history of chronic gastrointestinal disorders (ulcerative colitis, regional enteritis, or gastrointestinal bleeding);
- •Known hypersensitivity or allergy to modafinil, or receiving chronic therapy with any medication that could interact adversely with modafinil, including propranolol, phenytoin, warfarin and diazepam;
- •Took monoamine oxidase inhibitors (MAOI) within 30 days prior to randomization;
- •Taking or has taken an investigational drug within 60 days prior to randomization;
- •If female and of child-bearing capacity, tests positive on a urine pregnancy test, is lactating, has had three or more days of amenorrhea beyond expected menses at the time of the first dose of study medication, is contemplating pregnancy in the next 6 months, or is not using an effective contraceptive method;
- •Received therapy with any opiate-substitute (methadone, LAAM, buprenorphine) within 60 days of study enrollment.
研究组 & 干预措施
2
Placebo Comparator
placebo plus CBT
干预措施: placebo (Drug)
2
Placebo Comparator
placebo plus CBT
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
1
Experimental
modafinil plus CBT
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
1
Experimental
modafinil plus CBT
干预措施: Modafinil (Drug)
结局指标
主要结局
Percent of Participants Reporting no Cocaine Craving
时间窗: 8 weeks
Percent of participants reporting no cocaine craving based on Brief Substance Craving Scale (BSCS) - a 4 point likert scale.
Cocaine Use as Measured by Urine Drug Screen
时间窗: 8 weeks
The primary outcome measure was cocaine use measured by self-report, and confirmed by twice weekly urine drug screens. The percentage of participants shows the percentage who were abstinent from cocaine during the last 3 weeks of the trial.
次要结局
未报告次要终点
研究者
Kyle Kampman
Sponsor-Investigator
University of Pennsylvania
相似试验
已完成
2 期
Modafinil for the Treatment of Cocaine Dependence - 1Cocaine-Related DisordersNCT00100100National Institute on Drug Abuse (NIDA)210
Unknown
1 期
Evaluation of Modafinil as a Cocaine Treatment Medication and Interactions With Cocaine - 1Cocaine-Related DisordersDrug Administration ScheduleInfusions, IntravenousNCT00033046National Institute on Drug Abuse (NIDA)12
已完成
2 期
Modafinil for Smoked Cocaine Self-AdministrationCocaine DependenceNCT01778010New York State Psychiatric Institute8
已完成
1 期
Modafinil - Escitalopram Study for Cocaine DependenceCocaine DependenceCocaine AbuseCocaine AddictionSubstance AbuseNCT01601730Baylor College of Medicine68
已完成
1 期
Pharmacotherapy & CM for Opioid and Cocaine DependenceCocaine DependenceNCT00838981Yale University91