Combined Treatment for Cocaine-Alcohol Dependence - 1

Alcohol Dependence Clinical Trial

Official title:

Combined Treatment for Cocaine-Alcohol Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218569
• Other study ID #: NIDA-15801-1
• Secondary ID: R01DA015801R01-1
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2005
• Last updated: January 25, 2016
• Start date: April 2003
• Est. completion date: December 2007

Study information

• Verified date: January 2016
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

This is a randomized, double blind placebo-controlled trial to examine the role of Relapse Prevention (RP) and Contingency Management (CMP) combined with Naltrexone (NTX) for the treatment of cocaine-alcohol dependence. Patients will be randomly assigned to NTX (100mg/d) or placebo combined with one of two psychotherapy conditions (RP or RP +CMP). Following a standardized consent and intake procedure patients will participate in a 12-week trial with thrice weekly visits. Manual-guided RP therapy will be delivered in weekly 60-minute individual sessions. CMP will be based on cocaine-negative urine screens and negative breath alcohol tests. Follow-up assessments will be conducted at 3 and 6 months after treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Drug:
• Naltrexone
Naltrexone
• Placebo
Placebo

Locations

Country	Name	City	State
United States	University of Texas Health Sci Cntr Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine toxicology for cocaine		12 weeks of study	No