Pharmacotherapy & CM for Opioid and Cocaine Dependence

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

To investigate the role of modafinil-related improvements in memory, impulse control, and attention in mediating cocaine abstinence.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Analgesics, Opioid; Armodafinil; Cocaine; Methadone; Modafinil

Criteria

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.