View Clinical Trial (Medical Research Study)
Pharmacotherapy & CM for Opioid and Cocaine Dependence - NCT00838981-06516(Clinical Trial 270388)
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| City: |
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West Haven |
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State:
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CT |
| Zip Code: |
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06516 |
| Conditions: |
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Treatment for Cocaine Addiction - Lower Cocaine Use - Improve Memory - Impulse Control |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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Inclusion 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. |
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| Study is available at: |
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Department of Veterans Affairs
West Haven, CT 06516
United States
Primary Contact:
James Poling, Ph.D.
Email: james.poling@yale.edu
Phone: 203-932-5711 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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above to view all information about this clinical trial. |
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