Pharmacotherapy & CM for Opioid and Cocaine Dependence

Phase 1

Completed

Interventions: Drug: Sugar Pill
Drug: Modafinil
Behavioral: Contingency Management
Drug: Methadone
Behavioral: cognitive behavioral treatment
Behavioral: Voucher Control

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.

To investigate the role of modafinil-related improvements in memory, impulse control, and attention in mediating 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 hypothesize that improvements in memory, impulse control, and attention will be a significant contributor to the treatment improvements investigated in Specific Aim #1.

Opioid and cocaine dependence are major problems among veteran and non-veterans and no effective pharmacotherapy exists for cocaine dependence. Methadone has not shown robust effectiveness in reducing cocaine abuse. Thus, new treatments are needed for the individuals who have developed cocaine dependence. This study is designed to test a new pharmacotherapy for cocaine dependence and is a placebo-controlled trial.

Recruitment & Eligibility

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 Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Modafinil Plus Contingency Magagement	Contingency Management	Modafinil from 200mg up to 400mg plus Contingency Management
Modafinil Plus Contingency Magagement	cognitive behavioral treatment	Modafinil from 200mg up to 400mg plus Contingency Management
Sugar Pill Plus Contingency Management	Sugar Pill	Placebo: sugar pill
Sugar Pill Plus Contingency Management	Contingency Management	Placebo: sugar pill
Sugar Pill Plus Contingency Management	cognitive behavioral treatment	Placebo: sugar pill
Modafinil Plus Voucher Control	cognitive behavioral treatment	-
Modafinil Plus Voucher Control	Voucher Control	-
Sugar Pill Plus Voucher Control	Sugar Pill	-
Sugar Pill Plus Voucher Control	cognitive behavioral treatment	-
Sugar Pill Plus Voucher Control	Voucher Control	-
Modafinil Plus Contingency Magagement	Modafinil	Modafinil from 200mg up to 400mg plus Contingency Management
Modafinil Plus Contingency Magagement	Methadone	Modafinil from 200mg up to 400mg plus Contingency Management
Sugar Pill Plus Contingency Management	Methadone	Placebo: sugar pill
Modafinil Plus Voucher Control	Methadone	-
Modafinil Plus Voucher Control	Modafinil	-
Sugar Pill Plus Voucher Control	Methadone	-