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Combined Treatment for Cocaine-Alcohol Dependence - 1

Primary Purpose

Alcohol Dependence, Cocaine Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Naltrexone
Placebo
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol Dependence, Cocaine Dependence

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Texas Health Sci Cntr Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Naltrexone

Placebo

Outcomes

Primary Outcome Measures

Urine toxicology for cocaine

Secondary Outcome Measures

Full Information

First Posted
September 20, 2005
Last Updated
January 25, 2016
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00218569
Brief Title
Combined Treatment for Cocaine-Alcohol Dependence - 1
Official Title
Combined Treatment for Cocaine-Alcohol Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, Cocaine Dependence
Keywords
Alcohol Dependence, Cocaine Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Naltrexone
Arm Title
2
Arm Type
Experimental
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Other Intervention Name(s)
Naltrexone 100mg/day
Intervention Description
Naltrexone
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Urine toxicology for cocaine
Time Frame
12 weeks of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy Schmitz, Ph.D.
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Sci Cntr Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Combined Treatment for Cocaine-Alcohol Dependence - 1

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