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
  Purpose

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
Treatment for Cocaine Addiction
Lower Cocaine Use
Improve Memory
Impulse Control
Drug: Modafinil
Drug: Sugar Pill

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

Resource links provided by NLM:


Further study details as provided by 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. ] [ Designated as safety issue: No ]

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
Other Name: Modafinil
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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 ClinicalTrials.gov identifier: NCT00838981

Locations
United States, Connecticut
Department of Veterans Affairs
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Mehmet Sofuoglu, M.D.,Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Mehmet Sofuoglu, Principle Investigator, Yale University
ClinicalTrials.gov Identifier: NCT00838981     History of Changes
Other Study ID Numbers: 0705002636, R01DA021264, DPMC
Study First Received: February 6, 2009
Last Updated: June 13, 2014
Health Authority: United States: Federal Government

Keywords provided by Yale University:
Treatment for addiction
Methadone given for opioid dependence
Cocaine
Opiates

Additional relevant MeSH terms:
Cocaine
Modafinil
Armodafinil
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Wakefulness-Promoting Agents
Central Nervous System Stimulants

ClinicalTrials.gov processed this record on October 16, 2014