The purpose of this study is to evaluate the efficacy and tolerability of the combination of modafinil and naltrexone for the treatment of patients addicted to both cocaine and alcohol

Condition	Intervention	Phase
Alcohol-Related Disorders Alcoholism Cocaine Abuse, Cocaine-Related Disorders alcohol & drug use	Drug: Naltrexone	Phase II

Further Study Details: 

The hypotheses will be tested with a 4-group design to assess the efficacy of modafinil, naltrexone and the combination of the two medications compared to placebo. We will follow NIAAA''''s COMBINE Medical Management (MM) manual in weekly dispensing medications, safety checks and medication adherence. The psychosocial treatment will be Cognitive Behavioral Coping Skills Therapy (CBT). Subjects will be 200 men and women with current DSM-IV diagnoses of both cocaine and alcohol dependence who will be randomized to one of the four groups (50 subjects per group). All subjects will receive weekly sessions of CBT. The study length for each subject is comprised of 1 week of screening, a 13-week double-blind, placebo-controlled trial with CBT (medication phase), and one follow-up visit 6 months after signing informed consent.

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Male and females, 18-70 years old.
• Meets DSM-IV criteria for current diagnoses of cocaine and alcohol dependence, determined by the SCID-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, 1995)
• drank within 30 days of intake day,
• 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
• 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.
• Five 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, 1989) score below eight,.
• Lives a commutable distance from the TRC and agrees to attend all research visits including

follow-up visits.

-Speaks, understands, and prints in English

Exclusion Criteria:

• 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), determined by the SCID. Subjects who test positive on the urine drug screen (with the exception of cocaine) in the week prior to the randomization visit will be excluded (only one repeat testing permitted).
• Needs treatment with any psychoactive medications including any anti-seizure medications (with the exception of diphenhydramine used sparingly, if necessary, for sleep).
• Meets DSM-IV criteria for the following current Axis I disorders: panic, obsessive-compulsive, post-traumatic stress, or eating disorders. Subjects who meet current or lifetime DSM-IV criteria for schizophrenia or any psychotic disorder, or organic mental disorder.
• 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).

• 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 3.5x normal) of aspartate aminotransferase (AST), and serum glutamic-pyruvic transaminase (SGPT) after the required 3 days of abstinence.
• Use of an investigational medication in the 30 days prior to randomization.
• History of hypersensitivity to modafinil or naltrexone
• Receiving chronic therapy with any drug known to interact adversely with either modafinil or naltrexone including propranolol, phenytoin, warfarin, diazepam
• Took and monoamine oxidase inhibitor within 30 days of randomization.
• 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.
• Taking orhas taken an investigational drug within 60 days prior to randomization
• Current use of an oral contraceptive.
• Received therapy with any opiate substitute (methadone, LAAM, buprenorphine) within 60 days of randomization

Please refer to this study by ClinicalTrials.gov identifier  NCT00142818

Pennsylvania
      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104 6178,  United States

Study chairs or principal investigators

Helen M Pettinati, Ph.D.,  Principal Investigator,  University of Pennsylvania   

Study ID Numbers:  NIDA-12756-3; P50-12756-3
Last Updated:  September 1, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00142818
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-06