Combined Treatment for Cocaine-Alcohol Dependence - 1

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00218569
• Date of registration: 20/09/2005
• Primary sponsor: National Institute on Drug Abuse (NIDA)
• Public title: Combined Treatment for Cocaine-Alcohol Dependence - 1
• Scientific title: Combined Treatment for Cocaine-Alcohol Dependence
• Date of first enrolment: April 2003
• Target sample size: 87
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00218569
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Joy Schmitz, Ph.D.
• Affiliation: The University of Texas Health Science Center, Houston

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Alcohol Dependence

Cocaine Dependence

Intervention(s)

Drug: Naltrexone

Drug: Placebo

Primary Outcome(s)

Urine toxicology for cocaine [Time Frame: 12 weeks of study]

Secondary ID(s)

NIDA-15801-1

R01-15801-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The University of Texas Health Science Center, Houston