Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse

NCT ID: NCT01967381

Last Updated: 2018-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2018-09-30

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.

Conditions

Methamphetamine Abuse; Methamphetamine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Arm 1

Subjects will be maintained on oral placebo.

Group Type: PLACEBO_COMPARATOR

Methamphetamine (Desoxyn®)

Intervention Type: DRUG

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

Arm 2

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

Group Type: EXPERIMENTAL

Methamphetamine (Desoxyn®)

Intervention Type: DRUG

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

Arm 3

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

Group Type: EXPERIMENTAL

Methamphetamine (Desoxyn®)

Intervention Type: DRUG

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

Arm 4

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

Group Type: EXPERIMENTAL

Methamphetamine (Desoxyn®)

Intervention Type: DRUG

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

Interventions

Methamphetamine (Desoxyn®)

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

Intervention Type: DRUG

Eligibility Criteria

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®)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Kentucky

OTHER

Sponsor Role: lead

Responsible Party

Craig Rush

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Kentucky Medical Center

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

R01DA033394

Identifier Type: NIH

Identifier Source: org_study_id

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