Topiramate-Phentermine Combinations for Cocaine Dependence

NCT02239913 | Completed Phase 1 DMC

• 2 other identifiers: BED IN 27R01DA032254
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cocaine Use Disorder

Keywords

Cocaine; Pharmacotherapy; Phentermine; Topiramate; Self-Administration

Outcome Measures

Primary Outcomes (1)

• Reinforcing Effects

  The reinforcing effects of cocaine will be determined using a self-administration procedure in which subjects choose to take previously sampled doses.

  Nine times over approximately five weeks inpatient admission.

Secondary Outcomes (3)

• Subjective effects

  Nine times over approximately five weeks inpatient admission.

• Physiological Effects

  Daily over approximately five week inpatient admissions

• Side effects

  Daily over approximately five weeks of inpatient admission

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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.

Drug: Cocaine; Drug: Placebo; Drug: Phentermine

Topiramate Dose 1

EXPERIMENTAL

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.

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

Topiramate Dose 2

EXPERIMENTAL

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.

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

Interventions

Cocaine DRUG

The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and topiramate.

Placebo; Topiramate Dose 1; Topiramate Dose 2

Placebo DRUG

The pharmacodynamic effects of placebo will be determined during maintenance on placebo and topiramate.

Placebo; Topiramate Dose 1; Topiramate Dose 2

Phentermine DRUG

The pharmacodynamic effects of phentermine maintenance will be determined during maintenance on placebo and topiramate.

Also known as: Adipex®

Placebo; Topiramate Dose 1; Topiramate Dose 2

Topiramate DRUG

The pharmacodynamic effects of chronic topiramate will be determined.

Also known as: Topamax®

Topiramate Dose 1; Topiramate Dose 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Recent cocaine use by the intranasal or intravenous route

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kentucky: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Interventions

Cocaine; Phentermine; Topiramate

Intervention Hierarchy (Ancestors)

Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Amphetamines; Phenethylamines; Ethylamines; Amines; Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Craig R Rush, Ph.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 15, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: November 27, 2019

Record last verified: 2019-11

Locations

US (1)