Topiramate-Phentermine Combinations for Cocaine Dependence

University of Kentucky

Status and phase: Completed; Phase 1

Conditions: Cocaine Use Disorder

Treatments: Drug: Cocaine; Drug: Phentermine; Drug: Topiramate; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02239913

BED IN 27

R01DA032254 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will determine the influence of topiramate (Topamax®) and phentermine (Adipex®), alone and in combination, on the reinforcing, subjective and physiological effects of cocaine.

Enrollment: 38 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Recent cocaine use by the intranasal or intravenous route

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, topiramate or phentermine

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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38 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Cocaine

Drug: Phentermine

Topiramate Dose 1

Experimental group

Description:

Subjects will be maintained on the low topiramate dose. Subjects will be maintained on placebo and phentermine during maintenance on the low dose of topiramate. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.

Treatment:

Drug: Placebo

Drug: Topiramate

Drug: Cocaine

Drug: Phentermine

Topiramate Dose 2

Experimental group

Description:

Subjects will be maintained on the high topiramate dose. Subjects will be maintained on placebo and phentermine during maintenance on the high dose of topiramate. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.

Treatment:

Drug: Placebo

Drug: Topiramate

Drug: Cocaine

Drug: Phentermine