Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse

University of Kentucky

Status and phase: Completed; Early Phase 1

Conditions: Methamphetamine Dependence; Methamphetamine Abuse

Treatments: Drug: Methamphetamine (Desoxyn®)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01967381

R01DA033394

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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®)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 4 patient groups, including a placebo group

Arm 1

Placebo Comparator group

Description:

Subjects will be maintained on oral placebo.

Treatment:

Drug: Methamphetamine (Desoxyn®)

Arm 2

Experimental group

Description:

Subjects will be maintained on oral oxazepam (Serax®).

Treatment:

Drug: Methamphetamine (Desoxyn®)

Arm 3

Experimental group

Description:

Subjects will be maintained on oral naltrexone (Revia®).

Treatment:

Drug: Methamphetamine (Desoxyn®)

Arm 4

Experimental group

Description:

Subjects will be maintained on oral naltrexone (Revia®) and oral oxazepam (Serax®).

Treatment:

Drug: Methamphetamine (Desoxyn®)