Modafinil and Naltrexone to Reduce Cocaine and Alcohol Dependence
Condition: Alcohol-Related Disorders; Alcoholism; Cocaine-Related Disorders
MeSH terms: Alcoholism; Cocaine-Related Disorders; Alcohol-Related Disorders
Intervention: Naltrexone; Modafinil; Placebo
Intervention description: 150 mg daily for males; 100 mg daily for females; 400 mg daily; 400 mg and/or 100-150 mg placebo pills
Intervention MeSH terms: Naltrexone; Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 164.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alcohol Abuse; Cocaine Abuse

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.
    

Eligibility criteria:

        4.1 Inclusion Criteria

          1. Male and females, 18 years of age or older.

          2. Meets DSM-IV criteria for current diagnoses of cocaine and alcohol dependence,
             determined by the SCID-IV.

          3. 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, 1995):

               1. drank within 30 days of intake day,

               2. reports a minimum of 48 standard alcoholic (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

               3. 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.

          4. 72 consecutive hours of abstinence from alcohol, determined by self-reports and
             confirmed by a negative breathalyzer tests, and a Clinical Institute Withdrawal Scale
             for Alcohol (CIWA-AR) (Sullivan, 1989) score below eight. Subjects will be encouraged
             to achieve 72 consecutive hours of abstinence, however, subjects who have achieved
             between 48 and 72 consecutive hours 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 alcohol abstinence prior to
             randomization.

          5. Lives a commutable distance from the TRC and agrees to attend all research visits
             including follow-up visits.

          6. Speaks, understands, and prints in English

          7. Ability to give informed consent

        Exclusion Criteria

          1. Abstinent from cocaine or alcohol for 30 consecutive days prior to signing consent
             form.

          2. Meets DSM IV criteria for dependence on any substance other than cocaine and alcohol
             (except nicotine), determined by the SCID.

          3. Needs treatment with any psychoactive medications including any anti-seizure
             medications (with the exception of diphenhydramine used sparingly, if necessary, for
             sleep).

          4. Meets current or lifetime 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.

          5. Has evidence of a history of significant hematological, pulmonary, endocrine,
             cardiovascular, renal or gastrointestinal disease (including a history of myocardial
             infarction, mitral valve prolapse, left ventricular hypertrophy, uncontrolled
             hypertension).

          6. Severe physical or medical illnesses such as AIDS, active hepatitis, significant
             hepatocellular injury as evidenced by elevated total bilirubin levels (>1.3 mg/dl),or
             elevated levels (over 4.5x normal) of aspartate aminotransferase (AST), and serum
             glutamic-pyruvic transaminase (SGPT) after the required 3 days of abstinence.

          7. Use of an investigational medication in the 30 days prior to randomization.

          8. History of hypersensitivity to modafinil or naltrexone

          9. Receiving chronic therapy with any drug known to interact adversely with either
             modafinil or naltrexone including propranolol, phenytoin, warfarin, diazepam

         10. Took a monoamine oxidase inhibitor within 30 days of randomization.

         11. 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, female condom), intrauterine progesterone contraceptive
             system, levonorgrestrel implant, and medroxyprogeterone acetate contraceptive
             injection, copper IUD, vaginal contraceptive film, cervical cap, contraceptive foam.

         12. Current use of an oral contraceptive without other acceptable barrier method of
             contraception.

         13. Received therapy with any opiate substitute (methadone, LAAM, buprenorphine) within 60
             days of randomization