NCT01218984 - ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 31, 2002

Primary Completion Date

May 31, 2003

Study Completion Date

May 31, 2003

Conditions

Opiate Dependence

Interventions

DRUG

Medisorb naltrexone 75 mg

Single administration via intramuscular (IM) injection.

DRUG

Medisorb naltrexone 150 mg

Single administration via IM injection.

DRUG

Medisorb naltrexone 300 mg

Single administration via IM injection.

DRUG

Hydromorphone (10 mg/mL)

Increasing doses of 0, 3, 4.5, and 6 mg were administered at baseline (pre-study drug administration). After study drug administration, additional hydromorphone challenge sessions consisting of administering 0, 3, 4.5, and 6 mg were administered at 1-hr intervals at each of the postdose evaluation visits. In addition, at a randomly selected evaluation visit, subjects received four 0 mg (placebo) doses at 1-hour intervals.

DRUG

Naloxone Challenge and Oral Naltrexone Tolerability Testing

Administered according to the instructions provided by the respective manufacturer. Testing occurred at least 7 days after the baseline hydromorphone challenge and prior to study drug administration.