Pharmacotherapy & CM for Opioid and Cocaine Dependence
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
| Estimated Enrollment: | 160 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 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 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:
- 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| 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
No publications provided
| Responsible Party: | James Poling, 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: | January 31, 2013 |
| 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:
|
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 |
ClinicalTrials.gov processed this record on May 19, 2013