Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse

Early Phase 1

Completed

• Conditions: Methamphetamine Abuse; Methamphetamine Dependence
• Interventions: Drug: Methamphetamine (Desoxyn®)

• Registration Number: NCT01967381
• Lead Sponsor: University of Kentucky

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-15
• Study First Submitted QC: 2013-10-17
• Study First Posted: 2013-10-22
• Status Verified: 2018-09
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Methamphetamine (Desoxyn®)	Subjects will be maintained on oral placebo.
Arm 2	Methamphetamine (Desoxyn®)	Subjects will be maintained on oral oxazepam (Serax®).
Arm 3	Methamphetamine (Desoxyn®)	Subjects will be maintained on oral naltrexone (Revia®).
Arm 4	Methamphetamine (Desoxyn®)	Subjects will be maintained on oral naltrexone (Revia®) and oral oxazepam (Serax®).

Primary Outcome Measures

Name	Time	Method
Reinforcing Effects	After at least four days of placebo, oxazepam (Serax®), naltrexone (Revia®) or oxazepam and naltrexone maintenance	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.

Secondary Outcome Measures

Name	Time	Method
Subjective Effects	12 sessions over approximately 4 week inpatient admissions	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.
Physiological and Side Effects	Daily over approximately 4 week inpatient admissions	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.

Trial Locations

Locations (1)

University of Kentucky Medical Center; 🇺🇸 Lexington, Kentucky, United States