Combined Treatment for Cocaine-Alcohol Dependence - 1

NCT00218569 | Completed Phase 2 DMC

• 3 other identifiers: NIDA-15801-1R01DA015801R01-15801-1
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine whether Naltrexone and cognitive behavioral therapy can be helpful in patients who want to stop using cocaine and alcohol.

Conditions

Alcohol Dependence; Cocaine Dependence

Keywords

Alcohol Dependence; Cocaine Dependence

Outcome Measures

Primary Outcomes (1)

• Urine toxicology for cocaine

  12 weeks of study

Study Arms (2)

1

EXPERIMENTAL

Naltrexone

Drug: Naltrexone

2

EXPERIMENTAL

Placebo

Drug: Placebo

Interventions

Naltrexone DRUG

Naltrexone

Also known as: Naltrexone 100mg/day

1

Placebo DRUG

Placebo

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Give informed consent
• Be able to understand the nature of the study, agree to comply with study requirements, report regularly for scheduled visits, and communicate with study personnel about adverse events and concomitant medication use
• Be between 18 and 60 years old
• Meet DSM-IV criteria for both current cocaine and alcohol dependence
• Be in acceptable health based on physical exam, lab tests, and EKG
• Have a stable living situation and the availability of at least two locators
• Be able to read and write English at the 6th grade level
• Provide a least one cocaine positive urine during intake
• If female, must agree to use contraception

You may not qualify if:

• History of evidence of a medical condition that would expose them to an undue risk or interfere with assessments during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, or neurologic disease as determined by the clinical judgment of the research team
• Medical condition that is contraindicated with opioid antagonists or necessitates opiate medication
• Abnormal liver function test results (both ALT and AST \>3x upper limit normal or either \>5x upper limit normal)
• Currently in treatment or have received treatment in the past six months for substance abuse or another psychiatric condition
• Evidence of a Axis I disorder that will interfere with the course of the trial, including but not limited to current Major Depressive Disorder, Bipolar Disorder, Panic Disorder, Schizophrenia, Bulimia nervosa or Anorexia, and Post-traumatic stress disorder as determined by the clinical judgment of the research team
• Participating in 12 step meetings more than twice weekly
• Opiate abuse or dependence in the last five years or used opiates, barbiturates, benzodiazepines in the last thirty days
• Current dependence on any psychoactive disorder other than nicotine
• Impending incarceration
• Condition of probation or parole requiring reports of drug use to officers of the court
• Women of child bearing potential must not be pregnant/lactating or unwilling to use an acceptable contraceptive method
• Plans to move from the Houston area within the next three months

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Texas Health Sci Cntr Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Alcoholism; Cocaine-Related Disorders

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; 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

Study Officials

• Joy Schmitz, Ph.D.

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Psy, Behavioral Science

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: April 1, 2003
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: January 27, 2016

Record last verified: 2016-01

Locations

US (1)