Conditions: Cocaine Use Disorder
Keywords: cocaine phendimetrazine pharmacotherapy
Allocation: NON_RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 11
Healthy volunteers: yes

Brief summary:
This study will determine the safety and tolerability of phendimetrazine (Bontril®) as a pharmacotherapy for cocaine use disorder. A rigorous, inpatient human laboratory study will be conducted in which the subjective and physiological effects of cocaine are evaluated during maintenance on placebo and phendimetrazine.

Detailed description:

Arms:
arm 1: Subjects will be maintained on oral placebo. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. arm 2: Subjects will be maintained on the low phendimetrazine dose. Cocaine will be administered acutely during low dose phendimetrazine maintenance.

Placebo will be administered acutely during low dose phendimetrazine maintenance. arm 3: Subjects will be maintained on the intermediate phendimetrazine dose. Cocaine will be administered acutely during intermediate dose phendimetrazine maintenance.

Placebo will be administered acutely during intermediate dose phendimetrazine maintenance. arm 4: Subjects will be maintained on the high phendimetrazine dose. Cocaine will be administered acutely during high dose phendimetrazine maintenance.

Placebo will be administered acutely during high dose phendimetrazine maintenance.

Interventions: intervention 1: Cocaine intervention 2: Placebo
Intervention descriptions: intervention 1: The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and phendimetrazine. intervention 2: The pharmacodynamic effects of placebo will be determined during maintenance on placebo and phendimetrazine.

Protocol document: