Cocaine Use Disorder
Conditions
Keywords
Cocaine, Pharmacotherapy, Phentermine, Topiramate, Self-Administration
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.
Interventions
DRUGCocaine
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and topiramate.
DRUGPlacebo
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and topiramate.
DRUGPhentermine
The pharmacodynamic effects of phentermine maintenance will be determined during maintenance on placebo and topiramate.
DRUGTopiramate
The pharmacodynamic effects of chronic topiramate will be determined.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Kentucky
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reinforcing Effects | 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
| Measure | Time frame | Description |
|---|---|---|
| Physiological Effects | 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. |
| Subjective effects | 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. |
| Side effects | 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. |
Countries
United States
Outcome results
None listed