Phase 1Completed
A Study to Evaluate Abuse Potential of Istradefylline
A Double-Blind, Randomized, Placebo- and Active-Controlled Crossover Study to Evaluate the Abuse Potential of Istradefylline in Recreational Drug Users
- Sponsor
- Kyowa Kirin Co., Ltd. (Industry)
- Enrollment
- 42 enrolled
- Conditions
- Drug Abuse
- Interventions
- Istradefylline; Phentermine 45 mg; Placebo
- Ages
- adults
- Registry
- NCT02609477
Full record on ClinicalTrials.gov
From the registry
This study is to evaluate the abuse potential of single-doses of istradefylline compared to placebo and phentermine in recreational stimulant users. Subjects will participate in an outpatient medical Screening visit, a 5-day Qualification (Drug Discrimination) Phase, a 6-period Treatment Phase, and an outpatient safety Follow-Up visit. Study will be approximately 25 weeks total. Within 28 days of the Screening visit, eligible subjects will be admitted to the CRU (Day -1) for the Qualification Phase. During the Qualification Phase, subjects will receive single oral doses of phentermine 60 mg and matching placebo in a randomized, double blind, crossover manner, with each drug administration separated by approximately 48 hours (Day 1 and Day 3), to ensure that they can discriminate and show positive subjective effects of the active controls. Following evaluation of eligibility, subjects may be discharged (those who fail Qualification criteria) or remain in the CRU (those who pass criteria and are eligible) and then proceed directly to the Treatment Phase. The washout interval between…
Primary outcomes
- Drug Liking VAS
History
Last registry update
Primary completion
Started
Registered