Back to resultsTopiramate-Phentermine Combinations for Cocaine Dependence
Primary Purpose
Cocaine Use Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cocaine
Placebo
Phentermine
Topiramate
Sponsored by
About this trial
This is an interventional basic science trial for Cocaine Use Disorder focused on measuring Cocaine, Pharmacotherapy, Phentermine, Topiramate, Self-Administration
Eligibility 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
Sites / Locations
- University of Kentucky Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Topiramate Dose 1
Topiramate Dose 2
Arm 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.
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.
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.
Outcomes
Primary Outcome Measures
Reinforcing Effects
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
Subjective effects
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.
Physiological Effects
Physiological measures will be completed daily while subjects are admitted to our inpatient unit. Physiological measures include temperature, heart rate and blood pressure.
Side effects
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.
Full Information
NCT ID
NCT02239913
First Posted
September 10, 2014
Last Updated
November 25, 2019
Sponsor
University of Kentucky
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT02239913
Brief Title
Topiramate-Phentermine Combinations for Cocaine Dependence
Official Title
Topiramate-Phentermine Combinations for Cocaine Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kentucky
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Use Disorder
Keywords
Cocaine, Pharmacotherapy, Phentermine, Topiramate, Self-Administration
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Topiramate Dose 1
Arm Type
Experimental
Arm 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.
Arm Title
Topiramate Dose 2
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Cocaine
Intervention Description
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and topiramate.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and topiramate.
Intervention Type
Drug
Intervention Name(s)
Phentermine
Other Intervention Name(s)
Adipex®
Intervention Description
The pharmacodynamic effects of phentermine maintenance will be determined during maintenance on placebo and topiramate.
Intervention Type
Drug
Intervention Name(s)
Topiramate
Other Intervention Name(s)
Topamax®
Intervention Description
The pharmacodynamic effects of chronic topiramate will be determined.
Primary Outcome Measure Information:
Title
Reinforcing Effects
Description
The reinforcing effects of cocaine will be determined using a self-administration procedure in which subjects choose to take previously sampled doses.
Time Frame
Nine times over approximately five weeks inpatient admission.
Secondary Outcome Measure Information:
Title
Subjective effects
Description
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.
Time Frame
Nine times over approximately five weeks inpatient admission.
Title
Physiological Effects
Description
Physiological measures will be completed daily while subjects are admitted to our inpatient unit. Physiological measures include temperature, heart rate and blood pressure.
Time Frame
Daily over approximately five week inpatient admissions
Title
Side effects
Description
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.
Time Frame
Daily over approximately five weeks of inpatient admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig R Rush, Ph.D.
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Topiramate-Phentermine Combinations for Cocaine Dependence
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