Modafinil and Naltrexone to Reduce Cocaine and Alcohol Dependence

NCT00142818 | Completed Phase 2 Results DMC

• 3 other identifiers: NIDA-12756-3P50DA012756-03DPMC
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol-Related Disorders; Alcoholism; Cocaine-Related Disorders

Keywords

Alcohol Abuse; Cocaine Abuse

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Naltrexone plus modafinil

EXPERIMENTAL

Nal + Mod

Drug: Naltrexone; Drug: Modafinil

Naltrexone

EXPERIMENTAL

Nal

Drug: Naltrexone

Modafinil

EXPERIMENTAL

Mod

Drug: Modafinil

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Naltrexone DRUG

150 mg daily for males; 100 mg daily for females

Also known as: ReVia

Naltrexone; Naltrexone plus modafinil

Modafinil DRUG

400 mg daily

Also known as: Provigil

Modafinil; Naltrexone plus modafinil

Placebo DRUG

400 mg and/or 100-150 mg placebo pills

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and females, 18 years of age or older.
• 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 (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.
• 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.
• Lives a commutable distance from the TRC and agrees to attend all research visits including follow-up visits.
• Speaks, understands, and prints in English
• Ability to give informed consent

You may not qualify if:

• 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.
• Needs treatment with any psychoactive medications including any anti-seizure medications (with the exception of diphenhydramine used sparingly, if necessary, for sleep).
• 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.
• 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 4.5x 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 a 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.
• Current use of an oral contraceptive without other acceptable barrier method of contraception.
• Received therapy with any opiate substitute (methadone, LAAM, buprenorphine) within 60 days of randomization

Sponsors & Collaborators

• Kyle Kampman: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104 6178, United States

Location

MeSH Terms

Conditions

Alcohol-Related Disorders; Alcoholism; Cocaine-Related Disorders

Interventions

Naltrexone; Modafinil

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Kyle Kampman
• Organization: University of Pennsylvania

kampman@mail.med.upenn.edu

215-222-3200

Study Officials

• Kyle M. Kampman, M.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 2, 2005
• Study Start: February 1, 2006
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: July 16, 2020
• Results First Posted: August 29, 2014

Record last verified: 2020-07

Locations

US (1)