Pharmacotherapy & CM for Opioid and Cocaine Dependence

Cocaine Dependence Clinical Trial

Official title:

Pharmacotherapy & CM for Opioid and Cocaine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00838981
• Other study ID #: 0705002636
• Secondary ID: R01DA021264DPMC
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 2008
• Est. completion date: March 2014

Study information

• Verified date: December 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

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.

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Drug:
• Modafinil
Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.
• Sugar Pill
placebo, sugar pill will mirror active drug

Behavioral:
• Contingency Management
Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample.

Drug:
• Methadone
Subjects will be started on 30 mg of methadone and the dose will be increased as tolerated to reach 60 mg at the end of the first 1-2 weeks of the induction phase. Methadone dosing will bestabilized. During methadone maintenance (weeks 1-11 of treatment phase), subjects continue to receive their maintenance doses of methadone plus modafinil or placebo.

Behavioral:
• cognitive behavioral treatment
All subjects will receive a manual-guided CBT treatment over the course of their 16-week participation. This manual-guided therapy promotes abstinence through a functional analysis of high-risk situations and coping skills training.
• Voucher Control
Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that they will receive vouchers according to an unpredictable schedule, and that they cannot control when they will receive these vouchers or how much they will be worth.

Locations

Country	Name	City	State
United States	Department of Veterans Affairs	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Number of Positive Urine Tests	thrice weekly urine tests	up to 12 weeks.
Primary	Average Maximum Days Abstinent		up to 84 days
Secondary	Average Number of Days Using a Substance Within Treatment		up to 90 days