Naltrexone in Two Models of Psychosocial Treatments for Cocaine and Alcohol Dependence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Helen Pettinati, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00167232
First received: September 9, 2005
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to see whether naltrexone is safe and useful in preventing alcohol relapse, as well as in decreasing craving for alcohol in people with a diagnosis of alcohol and cocaine dependence. Naltrexone is approved by the Food and Drug Administration (FDA) for the treatment of alcohol dependence. However, the medication was not approved as yet at the dosage we will use in this study. The dosage we will use for the study (150 mg), is greater than the recommended dosage from the Physician's Desk Reference (50mg). Unlike other medicines (like Antabuse) useful in the treatment of alcohol dependence, naltrexone will not make you sick if you drink alcohol. Rather, people who are taking this medication have reported that it helps decrease the pleasure associated with drinking for them. This study is being conducted because the medication (Naltrexone) has not been well studied in people with both alcohol and cocaine dependence, so it is still investigational.

We believe that if we can reduce alcohol consumption through naltrexone and psychotherapy, this may lead to reduced cocaine use. We are also conducting this study to test two different types of psychotherapy as a method for reducing cocaine and alcohol use. One type of psychotherapy is designed to help people learn to cope with situations that put them at high risk for relapse to cocaine and/or alcohol use. The other type of psychotherapy we will use focuses on strengthening motivation to recover from cocaine and/or alcohol use, and on developing techniques to handle possible barriers to recovery. We seek to enroll 300 patients in the study.


Condition Intervention Phase
Cocaine Dependence
Alcoholism
Drug: Naltrexone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Naltrexone and Psychosocial Treatments for the Treatment of Cocaine Dependence Complicated by Alcohol Dependence

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Enrollment: 164
Study Start Date: January 1998
Study Completion Date: July 2003
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Naltrexone 150mg/day Drug: Naltrexone
Placebo Comparator: Placebo Sugar Pill

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria::

  • Male and females, 18-65 years old.
  • Meets DSM-IV criteria for current diagnoses of cocaine and alcohol dependence, determined by the SCID.
  • In the past 30 days, S used no less than $200-worth of cocaine and >15 standard alcohol drinks (avg)/week with at least 1 day of 4 or more drinks, determined by the TLFB--adapted to collect daily cocaine use.
  • Successful completion of medical detoxification, i.e., 5 consecutive days of abstinence from cocaine and alcohol, via self-reports and negative urine toxicology screens.
  • Lives a commutable distance to the TRC and agrees to follow-up visits.
  • Understands and signs the consent.

Exclusion Criteria::

  • Abstinent from cocaine or alcohol for 30 days prior to signing consent form. (S may have been institutionalized in the prior month and still be eligible if his/her cocaine and alcohol use that month met inclusion criteria.)
  • Current DSM-IV diagnosis of any substance dependence other than cocaine, alcohol, nicotine, or cannabis determined by the SCID.
  • Evidence of opiate use in the past 30 days, determined by self-report on the SCID or ASI, and/or by a urine drug screen that is positive for opiates at treatment entry.
  • Current treatment with psychotropic medications (excluding short-term use of benzodiazepines for detoxification), including disulfiram.
  • History of unstable or serious medical illness, including need for opioid analgesics.
  • History of epilepsy or seizure disorder.
  • Severe physical or medical illnesses such as AIDS, active hepatitis, significant hepatocellular injury as evidenced by elevated bilirubin levels, or elevated levels over 3.5x normal of aspartate aminotransferase (AST), and serum glutamic-pyruvic transaminase (SGPT).
  • Current severe psychiatric symptoms, e.g., psychosis, suicidal or homicidal ideation or mania.
  • Use of an investigational medication in the past 30 days.
  • Female Ss who are pregnant, nursing, or not using a reliable method of contraception. [Note: Criteria 4-10 will be assessed via the medical exam plus results from lab tests.]
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167232

Locations
United States, Pennsylvania
University of Pennsylvania- Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Helen M Pettinati, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Helen Pettinati, Principal Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00167232     History of Changes
Other Study ID Numbers: 57300, P60DA005186
Study First Received: September 9, 2005
Last Updated: September 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
naltrexone
cocaine dependence
alcohol dependence
psychosocial treatment

Additional relevant MeSH terms:
Alcoholism
Cocaine-Related Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Cocaine
Naltrexone
Anesthetics
Anesthetics, Local
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 29, 2014