Skip to main content
OpenTrials
Completed

NCT Number: NCT02239913

Topiramate-Phentermine Combinations for Cocaine Dependence

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cocaine Use Disorder

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cocaine

Drug

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

Placebo

Drug

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

Phentermine

Drug

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

Other names: Adipex®

Topiramate

Drug

The pharmacodynamic effects of chronic topiramate will be determined.

Other names: Topamax®

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Kentucky

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Sep 15, 2014
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.