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Phase 2 Completed N=52 Randomized Quadruple-blind Treatment

Improving Learning-based Treatment of Cocaine Dependence With Medication

COCAINE-RELATED DISORDERS
Source: ClinicalTrials.gov NCT01526538 ↗
Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcomePrimary: Urinalysis Benzoylecgonine (Cocaine Metabolite)(ng/ml) — 36.7; 32.4 ng/ml

Summary

This study will test the efficacy of d-cycloserine in enhancing response to learning-based treatment for cocaine dependence, specifically contingency management.

Outcome Measures

OutcomeResultp-value
PRIMARY
Urinalysis Benzoylecgonine (Cocaine Metabolite)(ng/ml)
36.7; 32.4
PRIMARY
Medication Side-effects
0; 0
SECONDARY
Learning Task by Itami and Uno
81.5; 72.9

Eligibility Criteria

Inclusion Criteria

  • 18-60 years of age (> 60 due to age-related effects on cognitive functioning)
  • Satisfy DSM-IV criteria for cocaine dependence (primarily crack)
  • Able to complete all study measures
  • Currently seeking treatment for cocaine dependence

Exclusion Criteria

  • Meets DSM-IV criteria for dependence on a drug other than cocaine or nicotine (may meet abuse criteria for other drugs)
  • Pregnant, breast feeding, or planning to become pregnant within 3 months
  • If female, do not agree to use an effective means of birth control during the course of treatment (via phone screen)
  • History of seizure disorder, severe hepatic impairment, porphyria, serious head trauma, dementia, or significant cognitive impairment
  • Diagnosis of current major psychiatric disorder besides substance dependence or abuse
  • Reported use of DCS in the past year
  • Illiteracy, as will be determined during in-person screening
  • Concurrently prescribed or using ethionamide or isoniazid (both used to treat tuberculosis)
  • Positive urine result for opioids at screening interview
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01526538). 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. Informational only — not medical advice.

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