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Pharmacotherapy & CM for Opioid and Cocaine Dependence

This study has been completed.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University Identifier:
First received: February 6, 2009
Last updated: July 7, 2015
Last verified: July 2015

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.

Condition Intervention
Cocaine Dependence Drug: Modafinil Drug: Sugar Pill

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pharmacotherapy & CM for Opioid and Cocaine Dependence

Resource links provided by NLM:

Further study details as provided by Mehmet Sofuoglu, Yale University:

Primary Outcome Measures:
  • 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. ]

Enrollment: 90
Study Start Date: May 2008
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Modafinil
Modafinil from 200mg up to 400mg
Drug: Modafinil
Modafinil will be phase in from 200mg to 400mg
Placebo Comparator: Sugar Pill
Placebo: sugar pill
Drug: Sugar Pill
placebo, sugar pill will mirror active drug
Other Name: Placebo

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 trail.

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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00838981

United States, Connecticut
Department of Veterans Affairs
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Mehmet Sofuoglu, M.D.,Ph.D. Yale University
  More Information

Responsible Party: Mehmet Sofuoglu, Principle Investigator, Yale University Identifier: NCT00838981     History of Changes
Other Study ID Numbers: 0705002636
R01DA021264 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
Study First Received: February 6, 2009
Last Updated: July 7, 2015

Keywords provided by Mehmet Sofuoglu, Yale University:
Treatment for addiction
Methadone given for opioid dependence

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers processed this record on July 27, 2017