Status:
COMPLETED
Pharmacotherapy & CM for Opioid and Cocaine Dependence
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to compare the efficacy of the combined treatment modafinil + Contingency Management (CM) to either treatment condition alone or to yoked-controls on cocaine abstinence. ...
Detailed Description
We hypothesize that the treatment group receiving the combination of modafinil + Contingency Management will have significantly lower cocaine use than the other treatment conditions. We also hypothesi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male and female opioid-dependent patients between the ages of 18-65 will be entered into the study. Females must not be pregnant as determined by pregnancy screening, nor breast feeding, and must be using acceptable birth control methods during study participation.
- Current opioid dependence as evidenced by documentation of prior treatment for opioid dependence or signs of withdrawal, self-reported history of opioid dependence for consecutive 12 month period and a positive urine for opiates.
- Subjects must fulfill DSM-IV criteria for opioid and cocaine dependence.
- Subjects must have a history of cocaine use, with a reported street cocaine use of a minimum of 1/2 gram during the preceding 30 days. Additionally, laboratory confirmation of recent cocaine use (positive urine for cocaine) within 2 weeks prior to admission to the study is required.
- Subjects must be treatment-seekers for opioid and cocaine use.
- Exclusion criteria:
- Current DSM-IV diagnosis of other drug or alcohol dependence (other than opiates, cocaine, or tobacco)
- History of heart disease, left ventricular hypertrophy, ischemic ECG changes, chest pain, arrhythmia, hypertension.
- History of severe renal, endocrine or hepatic diseases.
- History of psychosis, schizophrenia, or bipolar type I.
- History of seizure disorder.
- Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants).
- Liver function tests (SGOT,SGPT) greater than 3 times normal.
- Current use of modafinil
- Current suicidality
- Pregnancy or breast-feeding;
- Medical contraindication to treatment with study medication (e.g. for modafinil, history of heart disease, ischemic ECG changes, arrhythmia, hypertension).
- Women of child-bearing potential must agree to use other means of birth control and to have a pregnancy test repeated at least once monthly.
- Known allergy to modafinil or methadone.
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00838981
Start Date
May 1 2008
End Date
March 1 2014
Last Update
December 3 2021
Active Locations (1)
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1
Department of Veterans Affairs
West Haven, Connecticut, United States, 06516