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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01967381
Other study ID # R01DA033394
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date October 2013
Est. completion date September 2018

Study information

Verified date September 2018
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The research proposed in this application will determine the initial efficacy, safety and tolerability of a novel drug combination, oxazepam (Serax®) and naltrexone (Revia®), as a pharmacotherapy for methamphetamine (Desoxyn®) 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 combined oxazepam and naltrexone for managing methamphetamine dependence.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date September 2018
Est. primary completion date September 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Lifetime methamphetamine 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 methamphetamine (Desoxyn®), oxazepam (Serax®) or naltrexone (Revia®)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Methamphetamine (Desoxyn®)
The pharmacodynamic effects of methamphetamine (Desoxyn®) will be determined during placebo, oxazepam (Serax®), naltrexone (Revia®) and combined oxazepam and naltrexone maintenance.

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 methamphetamine 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, oxazepam (Serax®), naltrexone (Revia®), and oxazepam and naltrexone combined. After at least four days of placebo, oxazepam (Serax®), naltrexone (Revia®) or oxazepam and naltrexone maintenance
Secondary Subjective Effects Subjects will complete subjective effects measures during six sessions while they are admitted to our inpatient unit. These items will ask about drug effects and general mood. 12 sessions over approximately 4 week inpatient admissions
Secondary Physiological and Side Effects Physiological and side effects measures will be completed daily while subjects are admitted to our inpatient unit. Physiological measures include heart rate and blood pressure. Side Effects questions will query subjects about common effects of centrally active medications. Daily over approximately 4 week inpatient admissions
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