Phendimetrazine and Cocaine

William Stoops

Status and phase: Completed; Early Phase 1

Conditions: Cocaine Use Disorder

Treatments: Drug: Placebo; Drug: Cocaine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02233647

BED (IN) 29

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Recent cocaine use

Exclusion criteria

• Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
• Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
• History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
• Females not currently using effective birth control
• Contraindications to cocaine or phendimetrazine

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

11 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subjects will be maintained on oral placebo. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.

Treatment:

Drug: Placebo

Drug: Cocaine

Phendimetrazine Dose 1

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Cocaine

Phendimetrazine Dose 2

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Cocaine

Phendimetrazine Dose 3

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Cocaine