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| Sponsor: | Yale University |
|---|---|
| Collaborator: |
National Institute on Drug Abuse (NIDA) |
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00838981 |
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: Placebo or 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 |
| Estimated Enrollment: | 160 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | August 2011 (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: Placebo or sugar pill
placebo, sugar pill will mirror active drug
Other Name: Placebo
|
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 active and enrollment is continuing.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria
Contacts and Locations| United States, Connecticut | |
| Department of Veterans Affairs | Recruiting |
| West Haven, Connecticut, United States, 06516 | |
| Contact: James Poling, Ph.D. 203-932-5711 ext 4830 james.poling@yale.edu | |
| Principal Investigator: James Poling, PH.D. | |
| Principal Investigator: | James Poling, Ph.D. | Yale University |
More Information
| Responsible Party: | James Poling Ph.D, 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: | April 4, 2011 |
| Health Authority: | United States: Federal Government |
|
Treatment for addiction Methadone given for opioid dependence Cocaine Opiates |
|
Behavior, Addictive Cocaine-Related Disorders Compulsive Behavior Impulsive Behavior Substance-Related Disorders Mental Disorders Cocaine Modafinil Analgesics, Opioid Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Anesthetics, Local Anesthetics Central Nervous System Depressants Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Central Nervous System Stimulants Neuroprotective Agents Protective Agents Analgesics |