Pharmacotherapy & CM for Opioid and Cocaine Dependence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University
ClinicalTrials.gov Identifier:
NCT00838981
First received: February 6, 2009
Last updated: June 13, 2014
Last verified: June 2014

February 6, 2009
June 13, 2014
May 2008
March 2014   (final data collection date for primary outcome measure)
First, we will determine the success of the randomization by comparing the two treatment groups on social-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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00838981 on ClinicalTrials.gov Archive Site
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Not Provided
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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
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Treatment for Cocaine Addiction
  • Lower Cocaine Use
  • Improve Memory
  • Impulse Control
  • Drug: Modafinil
    Modafinil will be phase in from 200mg to 400mg
    Other Name: Modafinil
  • Drug: Sugar Pill
    placebo, sugar pill will mirror active drug
    Other Name: Placebo
  • Active Comparator: Modafinil
    Modafinil from 200mg up to 400mg
    Intervention: Drug: Modafinil
  • Placebo Comparator: Sugar Pill
    Placebo: sugar pill
    Intervention: Drug: Sugar Pill
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00838981
0705002636, R01DA021264, DPMC
Yes
Mehmet Sofuoglu, Yale University
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Mehmet Sofuoglu, M.D.,Ph.D. Yale University
Yale University
June 2014

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