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Alternative medications for the treatment of dually dependent on opiates and cocaine: a single-center placebo-controlled trial

Alternative medications for the treatment of dually dependent on opiates and cocaine: a single-center placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20170201001
Enrollment
50
Registered
2017-02-01
Start date
2016-02-10
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This study had several limitations. The most important restrictions were as follows: 1) the cross&#45

Interventions

Doses were scaled from small doses and the starting dose was 25 mg until maximum of 300 mg/day pills. The daily usage was divided to two dosages of morning and afternoon. The urine test band was rando
Creatinine and PH and threshold of 300 ng/ml was used for the urine analysis. All the topiramate capsules together with monohydrate lactose powder were provided less than sixty days before usage. Lact
Experimental Drug
Topiramate (TPM)

Sponsors

non
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 55 Years

Inclusion criteria

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: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 (7.74–16.10) with exp 12-week generalized estimating equations (GEE)

Contacts

Public Contactbijan pirnia

phD student

b.pirnia@usc.ac.ir+9802122081450

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026