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Pharmacotherapy & CM for Opioid and Cocaine Dependence
NCT00838981Phase 2
Key facts
- Status
- Completed
- Start
- May 2008
- Primary completion
- Mar 2014
- Countries
- 1
- Sponsor
- Yale University
- Modality
- Small Molecules
- Drugs
- modafinil
- Conditions
- cocaine dependence
01
Overview
Phase 2, randomised, double-blind trial of modafinil in cocaine dependence (4 arms), sponsored by Yale University. Primary endpoints: Average Number of Positive Urine Tests at 12 weeks and Average Maximum Days Abstinent at 84 days. Started May 2008; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Modafinil + CM
Modafinil + Contingency Management + Methadone + CBT
Placebo + CM
Placebo + Contingency Management + Methadone + CBT
Modafinil + Voucher Control
Modafinil + Voucher Control + Methadone + CBT
Placebo + Voucher Control
Placebo + Voucher Control + Methadone + CBT
03
Who it enrols
Opioid and cocaine-dependent patients aged 18-65 seeking treatment, with recent confirmed cocaine use, excluding those with severe medical or psychiatric conditions.
04
Endpoints
Primary
Average Number of Positive Urine Tests
Average Maximum Days Abstinent
Secondary
Average Number of Days Using a Substance Within Treatment
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