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Pharmacotherapy & CM for Opioid and Cocaine Dependence

Primary Purpose

Cocaine Dependence

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Modafinil

Sugar Pill

Contingency Management

Methadone

cognitive behavioral treatment

Voucher Control

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring Treatment for addiction, Methadone given for opioid dependence, Cocaine, Opiates

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Veterans Affairs

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Modafinil Plus Contingency Magagement

Sugar Pill Plus Contingency Management

Modafinil Plus Voucher Control

Sugar Pill Plus Voucher Control

Arm Description

Modafinil from 200mg up to 400mg plus Contingency Management

Placebo: sugar pill

Outcomes

Primary Outcome Measures

Average Number of Positive Urine Tests

thrice weekly urine tests

Average Maximum Days Abstinent

Secondary Outcome Measures

Average Number of Days Using a Substance Within Treatment

Full Information

NCT ID

NCT00838981

First Posted

February 6, 2009

Last Updated

December 1, 2021

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT00838981

Brief Title

Pharmacotherapy & CM for Opioid and Cocaine Dependence

Official Title

Pharmacotherapy & CM for Opioid and Cocaine Dependence

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cocaine Dependence

Keywords

Treatment for addiction, Methadone given for opioid dependence, Cocaine, Opiates

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

91 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Modafinil Plus Contingency Magagement

Arm Type

Active Comparator

Arm Description

Modafinil from 200mg up to 400mg plus Contingency Management

Arm Title

Sugar Pill Plus Contingency Management

Arm Type

Placebo Comparator

Arm Description

Placebo: sugar pill

Arm Title

Modafinil Plus Voucher Control

Arm Type

Active Comparator

Arm Title

Sugar Pill Plus Voucher Control

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Modafinil

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Sugar Pill

Other Intervention Name(s)

Placebo

Intervention Description

placebo, sugar pill will mirror active drug

Intervention Type

Behavioral

Intervention Name(s)

Contingency Management

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Methadone

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

cognitive behavioral treatment

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Voucher Control

Intervention Description

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.

Primary Outcome Measure Information:

Title

Average Number of Positive Urine Tests

Description

thrice weekly urine tests

Time Frame

up to 12 weeks.

Title

Average Maximum Days Abstinent

Time Frame

up to 84 days

Secondary Outcome Measure Information:

Title

Average Number of Days Using a Substance Within Treatment

Time Frame

up to 90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mehmet Sofuoglu, M.D.,Ph.D.

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Veterans Affairs

City

West Haven

State/Province

Connecticut

ZIP/Postal Code

06516

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Pharmacotherapy & CM for Opioid and Cocaine Dependence

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