Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse

NCT01967381 | Completed Early Phase 1 DMC

• 1 other identifier: R01DA033394
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Subjective Effects

  12 sessions over approximately 4 week inpatient admissions

• Physiological and Side Effects

  Daily over approximately 4 week inpatient admissions

Study Arms (4)

Arm 1

PLACEBO COMPARATOR

Subjects will be maintained on oral placebo.

Drug: Methamphetamine (Desoxyn®)

Arm 2

EXPERIMENTAL

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

Drug: Methamphetamine (Desoxyn®)

Arm 3

EXPERIMENTAL

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

Drug: Methamphetamine (Desoxyn®)

Arm 4

EXPERIMENTAL

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

Drug: Methamphetamine (Desoxyn®)

Interventions

Methamphetamine (Desoxyn®) DRUG

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

Arm 1; Arm 2; Arm 3; Arm 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Lifetime methamphetamine use

You may not qualify if:

• 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®)

Sponsors & Collaborators

• University of Kentucky: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Interventions

Methamphetamine

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: October 22, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 14, 2018

Record last verified: 2018-09

Locations

US (1)