Conditions: Pain Nausea Vomiting
Keywords: Pain Nausea Vomiting
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 40
Healthy volunteers: yes

Brief summary:
The purpose of this study is to assess the abuse potential of CL-108 tablets, including the abuse deterrent effects of promethazine, following oral administration, relative to hydrocodone/acetaminophen (APAP) tablets and placebo in non-dependent, recreational opioid users.

Detailed description:
The purpose of this study is to assess the abuse potential of CL-108 tablets, including the abuse deterrent effects of promethazine, following oral administration, relative to hydrocodone/acetaminophen (APAP) tablets and placebo in non-dependent, recreational opioid users; to assess the cognitive and behavioral effects of CL-108 tablets following oral administration relative to hydrocodone/APAP tablets and placebo in non-dependent, recreational opioid users; and to assess the safety of orally administered CL-108 tablets relative to hydrocodone/APAP tablets and placebo in non-dependent, recreational opioid users.

Arms:
arm 1: CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth arm 2: CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth arm 3: M366 22.5 mg/975 mg tablet by mouth arm 4: M366 37.5 mg/1625 mg tablet by mouth arm 5: Placebo 0 mg tablet by mouth

Interventions: intervention 1: CL-108 intervention 2: M366 intervention 3: Placebo
Intervention descriptions: intervention 1: 7.5 mg/325 mg/12.5 mg tablet intervention 2: 7.5 mg/325 mg tablet intervention 3: None

Protocol document: