Phase 2
N=91
Pharmacotherapy & CM for Opioid and Cocaine Dependence
Cocaine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00838981 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Average Number of Positive Urine Tests — 32; 30.2; 28.1; 31.4 urine tests
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Modafinil (Drug); Sugar Pill (Drug); Contingency Management (Behavioral); Methadone (Drug); cognitive behavioral treatment (Behavioral); Voucher Control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Number of Positive Urine Tests |
32; 30.2; 28.1; 31.4; 17.5; 16.1 | — |
| PRIMARY Average Maximum Days Abstinent |
69; 58.3; 67.2; 71.8; 30.9; 32.7 | — |
| SECONDARY Average Number of Days Using a Substance Within Treatment |
0.32; 1.8; 0.06; 0.13; 19; 15.6 | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00838981). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.