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Pharmacotherapy & CM for Opioid and Cocaine Dependence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00838981
First Posted: February 9, 2009
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University
February 6, 2009
February 9, 2009
May 5, 2017
September 12, 2017
September 12, 2017
May 2008
March 2014   (Final data collection date for primary outcome measure)
  • Average Number of Positive Urine Tests [ Time Frame: up to 12 weeks. ]
    thrice weekly urine tests
  • Average Maximum Days Abstinent [ Time Frame: up to 84 days ]
First, we will determine the success of the randomization by comparing the two treatment groups on socio-demographic and baseline clinical characteristics using chi-square for categorical variables and ANOVA for continuous variables. [ Time Frame: This is a 16-17 week study per subject over a total time period of 5 years. ]
Complete list of historical versions of study NCT00838981 on ClinicalTrials.gov Archive Site
Average Number of Days Using a Substance Within Treatment [ Time Frame: up to 90 days ]
Not Provided
Not Provided
Not Provided
 
Pharmacotherapy & CM for Opioid and Cocaine Dependence
Pharmacotherapy & CM for Opioid and Cocaine Dependence

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.

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 trail.

Currently this study is in data analysis phase with 90 enrolled and 70 completers.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Cocaine Dependence
  • 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.
  • Drug: Sugar Pill
    placebo, sugar pill will mirror active drug
    Other Name: Placebo
  • 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.
  • Behavioral: 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.
  • Active Comparator: Modafinil Plus Contingency Magagement
    Modafinil from 200mg up to 400mg plus Contingency Management
    Interventions:
    • Drug: Modafinil
    • Behavioral: Contingency Management
    • Drug: Methadone
    • Behavioral: cognitive behavioral treatment
  • Placebo Comparator: Sugar Pill Plus Contingency Management
    Placebo: sugar pill
    Interventions:
    • Drug: Sugar Pill
    • Behavioral: Contingency Management
    • Drug: Methadone
    • Behavioral: cognitive behavioral treatment
  • Active Comparator: Modafinil Plus Voucher Control
    Interventions:
    • Drug: Modafinil
    • Drug: Methadone
    • Behavioral: cognitive behavioral treatment
    • Behavioral: Voucher Control
  • Placebo Comparator: Sugar Pill Plus Voucher Control
    Interventions:
    • Drug: Sugar Pill
    • Drug: Methadone
    • Behavioral: cognitive behavioral treatment
    • Behavioral: Voucher Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
91
March 2014
March 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00838981
0705002636
R01DA021264 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
Yes
Not Provided
Plan to Share IPD: No
Yale University
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Mehmet Sofuoglu, M.D.,Ph.D. Yale University
Yale University
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP