Modafinil and Naltrexone to Reduce Cocaine and Alcohol Dependence

Phase 2

Completed

Conditions: Alcohol-Related Disorders
Alcoholism
Cocaine-Related Disorders

Interventions: Drug: Naltrexone
Drug: Placebo
Drug: Modafinil

Registration Number: NCT00142818

Lead Sponsor: Kyle Kampman

Brief Summary: Modafinil is a medication that may enhance mood and increase energy in cocaine addicts, which may be useful in preventing cocaine relapse. Naltrexone is a medication that is currently used to treat drug and alcohol addiction. A combination of these two medications may be beneficial in reducing drug and alcohol use in individuals undergoing substance abuse treatment. The purpose of this study is to evaluate the effectiveness of modafinil and naltrexone, alone and in combination, at reducing drug and alcohol use in individuals addicted to cocaine and alcohol.

Detailed Description: Cocaine and alcohol addiction are serious health problems with no available medical treatment for preventing relapse. Past research has shown that individuals who are addicted to both cocaine and alcohol typically respond poorly to conventional substance abuse treatment. Little attention has been directed towards how best to treat these individuals. Naltrexone is a medication that is currently used to treat drug and alcohol addiction. It acts by blocking the "high" feeling produced by drugs and alcohol. Modafinil, another medication, enhances mood, increases energy, and improves concentration in people with narcolepsy. Preliminary research has shown that it may produce similar effects to cocaine, thereby potentially countering the symptoms of cocaine withdrawal. Cognitive Behavioral Coping Skills Therapy (CBT), a form of therapy that aims to alter an individual's patterns of behavior and drug use, is also an important component of substance abuse treatment. The purpose of this study is to compare the effectiveness of CBT plus placebo, CBT plus modafinil, CBT plus naltrexone, and CBT plus a combination of modafinil and naltrexone at reducing cocaine and alcohol use in individuals addicted to both substances.

This 14-week study will enroll individuals addicted to both cocaine and alcohol. During a 1-week screening period, potential participants will be required to complete a detoxification program, including stopping all cocaine and alcohol use. Participants will also undergo a physical exam and an electrocardiogram. Blood will be drawn for laboratory tests, and urine tests will be used to screen for the presence of drugs and alcohol. Individuals who complete the screening and meet all study requirements will be permitted to participate in the treatment phase of the study. During the 13-week treatment phase, participants will be randomly assigned to receive modafinil, naltrexone, a combination of modafinil and naltrexone, or placebo. All participants will attend a CBT session once a week. Study visits will take place twice a week. At each visit, a urine test and breathalyzer will be used to screen for the presence of alcohol and drugs. Participants will also complete standardized psychological questionnaires to measure drug and alcohol craving, treatment services received, severity of illness, and withdrawal symptoms. In addition, participants will meet weekly with a nurse practitioner, who will dispense study medications, monitor adverse events, and evaluate the participant's clinical status. A follow-up evaluation will occur 6 months following the end of treatment.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 164

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naltrexone plus modafinil	Naltrexone	Nal + Mod
Naltrexone plus modafinil	Modafinil	Nal + Mod
Naltrexone	Naltrexone	Nal
Modafinil	Modafinil	Mod
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Cocaine Use (Measured by Timeline Follow Back and Urine Screen From Week 2-week 14)	13 weeks
Percent Days of Heavy Drinking (Measured by Timeline Follow Back Starting at Week Two Through Week 14	13 weeks

Secondary Outcome Measures