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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02239913
Other study ID # BED IN 27
Secondary ID R01DA032254
Status Completed
Phase Phase 1
First received
Last updated
Start date September 2014
Est. completion date September 2019

Study information

Verified date November 2019
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date September 2019
Est. primary completion date September 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Cocaine
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and topiramate.
Placebo
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and topiramate.
Phentermine
The pharmacodynamic effects of phentermine maintenance will be determined during maintenance on placebo and topiramate.
Topiramate
The pharmacodynamic effects of chronic topiramate will be determined.

Locations

Country Name City State
United States University of Kentucky Medical Center Lexington Kentucky

Sponsors (2)

Lead Sponsor Collaborator
University of Kentucky National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. Nine times over approximately five weeks inpatient admission.
Secondary 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. Daily over approximately five week inpatient admissions
Secondary 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. Daily over approximately five weeks of inpatient admission
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