Topiramate-Phentermine Combinations for Cocaine Dependence

Cocaine Use Disorder Clinical Trial

Official title:

Topiramate-Phentermine Combinations for Cocaine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02239913
• Other study ID #: BED IN 27
• Secondary ID: R01DA032254
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Cocaine Use Disorder
• Cocaine-Related Disorders

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