Pharmacokinetic and Safety Evaluation of L-tetrahydropalmatine (l-THP) With Cocaine Exposure in People With a History of Cocaine Use

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

June 30, 2017

Study Completion Date

June 30, 2017

Conditions
Cocaine Use
Interventions
DRUG

l-THP (l-tetrahydropalmatine)

Subjects will arrive the first day (Day 1) for admission and morning l-THP dosing. The l-THP will be dosed as one capsule 30 mg twice daily (matching placebo or l-THP) (total 60 mg daily). Participants will receive 7 total l-THP doses: two doses on Day 1 (morning and evening), two doses on Day 2 (morning and evening), 2 doses on Day 3 (morning and evening) and one dose the morning of Day 4 (cocaine administration day).

DRUG

Placebo

Subjects will arrive the first day (Day 1) for admission and morning l-THP dosing. The l-THP will be dosed as one capsule 30 mg twice daily (matching placebo or l-THP) (total 60 mg daily). Participants will receive 7 total l-THP doses: two doses on Day 1 (morning and evening), two doses on Day 2 (morning and evening), 2 doses on Day 3 (morning and evening) and one dose the morning of Day 4 (cocaine administration day).

Trial Locations (1)

21228

Maryland Psychiatric Research Center, Catonsville

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

University of Maryland, Baltimore

OTHER

NCT01631383 - Pharmacokinetic and Safety Evaluation of L-tetrahydropalmatine (l-THP) With Cocaine Exposure in People With a History of Cocaine Use | Biotech Hunter | Biotech Hunter