Pharmacotherapy & CM for Opioid and Cocaine Dependence

NCT00838981 | Completed Phase 1 Results DMC

• 3 other identifiers: 0705002636R01DA021264DPMC
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Dependence

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Average Number of Positive Urine Tests

  thrice weekly urine tests

  up to 12 weeks.

• Average Maximum Days Abstinent

  up to 84 days

Secondary Outcomes (1)

• Average Number of Days Using a Substance Within Treatment

  up to 90 days

Study Arms (4)

Modafinil Plus Contingency Magagement

ACTIVE COMPARATOR

Modafinil from 200mg up to 400mg plus Contingency Management

Drug: Modafinil; Behavioral: Contingency Management; Drug: Methadone; Behavioral: cognitive behavioral treatment

Sugar Pill Plus Contingency Management

PLACEBO COMPARATOR

Placebo: sugar pill

Drug: Sugar Pill; Behavioral: Contingency Management; Drug: Methadone; Behavioral: cognitive behavioral treatment

Modafinil Plus Voucher Control

ACTIVE COMPARATOR

Drug: Modafinil; Drug: Methadone; Behavioral: cognitive behavioral treatment; Behavioral: Voucher Control

Sugar Pill Plus Voucher Control

PLACEBO COMPARATOR

Drug: Sugar Pill; Drug: Methadone; Behavioral: cognitive behavioral treatment; Behavioral: Voucher Control

Interventions

Modafinil DRUG

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.

Modafinil Plus Contingency Magagement; Modafinil Plus Voucher Control

Sugar Pill DRUG

placebo, sugar pill will mirror active drug

Also known as: Placebo

Sugar Pill Plus Contingency Management; Sugar Pill Plus Voucher Control

Contingency Management BEHAVIORAL

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.

Modafinil Plus Contingency Magagement; Sugar Pill Plus Contingency Management

Methadone DRUG

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.

Modafinil Plus Contingency Magagement; Modafinil Plus Voucher Control; Sugar Pill Plus Contingency Management; Sugar Pill Plus Voucher Control

cognitive behavioral treatment BEHAVIORAL

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.

Modafinil Plus Contingency Magagement; Modafinil Plus Voucher Control; Sugar Pill Plus Contingency Management; Sugar Pill Plus Voucher Control

Voucher Control BEHAVIORAL

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.

Modafinil Plus Voucher Control; Sugar Pill Plus Voucher Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Department of Veterans Affairs

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Modafinil; Sugars; Methadone

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Carbohydrates; Ketones

Results Point of Contact

• Title: Mehmet Sofuoglu, M.D.,Ph.D.
• Organization: Yale University

mehmet.sofuoglu@yale.edu

203-937-4809

Study Officials

• Mehmet Sofuoglu, M.D.,Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 9, 2009
• Study Start: May 1, 2008
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: December 3, 2021
• Results First Posted: September 12, 2017

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)