Topiramate-Phentermine Combinations for Cocaine Dependence

November 25, 2019 updated by: Craig Rush, University of Kentucky
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
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
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and topiramate.
Drug: Placebo
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and topiramate.
Drug: Phentermine
The pharmacodynamic effects of phentermine maintenance will be determined during maintenance on placebo and topiramate.
Other Names:
  • Adipex®
Experimental: Topiramate Dose 1
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
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and topiramate.
Drug: Placebo
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and topiramate.
Drug: Phentermine
The pharmacodynamic effects of phentermine maintenance will be determined during maintenance on placebo and topiramate.
Other Names:
  • Adipex®
Drug: Topiramate
The pharmacodynamic effects of chronic topiramate will be determined.
Other Names:
  • Topamax®
Experimental: Topiramate Dose 2
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
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and topiramate.
Drug: Placebo
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and topiramate.
Drug: Phentermine
The pharmacodynamic effects of phentermine maintenance will be determined during maintenance on placebo and topiramate.
Other Names:
  • Adipex®
Drug: Topiramate
The pharmacodynamic effects of chronic topiramate will be determined.
Other Names:
  • Topamax®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reinforcing Effects
Time Frame: Nine times over approximately five weeks inpatient admission.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective effects
Time Frame: Nine times over approximately five weeks inpatient admission.
Subjects will complete subjective effects measures during nine sessions while they are admitted to our inpatient unit. These items will ask about drug effects and general mood.
Nine times over approximately five weeks inpatient admission.
Physiological Effects
Time Frame: Daily over approximately five week inpatient admissions
Physiological measures will be completed daily while subjects are admitted to our inpatient unit. Physiological measures include temperature, heart rate and blood pressure.
Daily over approximately five week inpatient admissions
Side effects
Time Frame: Daily over approximately five weeks of inpatient admission
Subjects will complete a side effects questionnaire daily while they reside on the inpatient unit. Side Effects questions will query subjects about common effects of centrally active medications.
Daily over approximately five weeks of inpatient admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kentucky

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Craig R Rush, Ph.D., University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

September 10, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (Estimate)

September 15, 2014

Study Record Updates

Last Update Posted (Actual)

November 27, 2019

Last Update Submitted That Met QC Criteria

November 25, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BED IN 27
  • R01DA032254 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cocaine Use Disorder

Clinical Trials on Cocaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe