Alternative medications for the treatment of dually dependent on opiates and cocaine: a single-center placebo-controlled trial
Phase 1
- Conditions
- This study had several limitations. The most important restrictions were as follows: 1) the cross-sectional nature of the study limits the overall conclusion and comprehensive forecastand 2) usingTopiramate (TPM),Anticonvulsants/adverse effects,drug therapy,placebo,Methadone Maintenance Treatment
- Registration Number
- TCTR20170201001
- Lead Sponsor
- non
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated (Halted Prematurely)
- Sex
- Male
- Target Recruitment
- 50
Inclusion Criteria
Inclusion criteria were: 1) young Male (18-55 year) patients; 2) diagnostic criteria for cocaine and opioid dependence according to DSM-IV and 3) eligible for methadone maintenance.
Exclusion Criteria
Exclusion criteria were: 1) report of positive urine test during the remedial period; 2) Hypersensitivity to TPM; 3) nephrolithiasis or renal impairment, kidney failure history, serious mental disorde
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method on a primary outcome, Topiramate was not better than placebo in reducing cocaine use 12-week generalized estimating equations (GEE) ,Topiramate was not better than placebo in reducing cocaine use 12-week generalized estimating equations (GEE)
- Secondary Outcome Measures
Name Time Method Secondary outcome was showed Topiramate was better than placebo in reducing cocaine craving 12-week generalized estimating equations (GEE) ,The mean [95% confidence interval (CI)] scores of cocaine craving was 11.42 (7.74â€16.10) with exp 12-week generalized estimating equations (GEE)