Cocaine Use Disorders Clinical Trial
Verified date | June 2018 |
Source | University of Kentucky |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The research proposed in this application will determine the initial efficacy, safety and tolerability of a novel drug combination, bupropion and naltrexone, as a pharmacotherapy for cocaine dependence. A rigorous, inpatient human laboratory study will be conducted. The proposed study is innovative and important because it will provide the impetus for the conduct of double blind, placebo-controlled trials to further demonstrate the efficacy of bupropion-naltrexone combinations for managing cocaine dependence.
Status | Completed |
Enrollment | 34 |
Est. completion date | June 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Recent cocaine use 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, bupropion or naltrexone, |
Country | Name | City | State |
---|---|---|---|
United States | University of Kentucky Medical Center | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Craig Rush | National Institute on Drug Abuse (NIDA) |
United States,
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. Reinforcing effects are measured during maintenance on placebo, bupropion, naltrexone, and bupropion-naltrexone combinations. | Twelve (12) times over approximately six (6) weeks inpatient admission. | |
Secondary | Subjective effects | Subjects will complete subjective effects measures during sessions while they are admitted to our inpatient unit. These items will ask about drug effects and general mood. | Twelve (12) times over approximately six (6) weeks inpatient admission. | |
Secondary | Physiological and side effects. | Physiological and side effects measures will be completed daily while subjects are admitted to our inpatient unit. Physiological measures included heart rate and blood pressure. Side effects questions will query subjects about common effects of centrally active medications. | Daily over approximately six (6) weeks inpatient admission. |
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