Clinical trial NCT00838981: Pharmacotherapy & CM for Opioid and Cocaine Dependence
Official title: Pharmacotherapy & CM for Opioid and Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cocaine Dependence
Keywords: Treatment for addiction
Methadone given for opioid dependence
Cocaine
Opiates
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2009-02-09
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Average Number of Positive Urine Tests
timeFrame: up to 12 weeks.
measure: Average Maximum Days Abstinent
timeFrame: up to 84 days
Secondary outcomes:
measure: Average Number of Days Using a Substance Within Treatment
timeFrame: up to 90 days
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Department of Veterans Affairs
state: Connecticut
Study officials:
affiliation: Yale University
name: Mehmet Sofuoglu, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: