We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Topiramate-Phentermine Combinations for Cocaine Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02239913
Recruitment Status : Completed
First Posted : September 15, 2014
Last Update Posted : November 27, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Craig Rush, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Cocaine Use Disorder Drug: Cocaine Drug: Placebo Drug: Phentermine Drug: Topiramate Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Topiramate-Phentermine Combinations for Cocaine Dependence
Actual Study Start Date : September 2014
Actual Primary Completion Date : September 2019
Actual Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Adipex®

Drug: Topiramate
The pharmacodynamic effects of chronic topiramate will be determined.
Other Name: 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 Name: Adipex®

Drug: Topiramate
The pharmacodynamic effects of chronic topiramate will be determined.
Other Name: Topamax®




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02239913


Locations
Layout table for location information
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
University of Kentucky
National Institute on Drug Abuse (NIDA)
Investigators
Layout table for investigator information
Principal Investigator: Craig R Rush, Ph.D. University of Kentucky
Layout table for additonal information
Responsible Party: Craig Rush, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT02239913    
Other Study ID Numbers: BED IN 27
R01DA032254 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2014    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Keywords provided by Craig Rush, University of Kentucky:
Cocaine
Pharmacotherapy
Phentermine
Topiramate
Self-Administration
Additional relevant MeSH terms:
Layout table for MeSH terms
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Topiramate
Phentermine
Cocaine
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Central Nervous System Stimulants
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Adrenergic Agents