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Completed

NCT Number: NCT01967381

Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse

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.

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Key information

Conditions

Methamphetamine Abuse Methamphetamine Dependence

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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®)

Treatment and study plan

Methamphetamine (Desoxyn®)

Drug

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

Primary outcomes

  1. Reinforcing Effects

    Time frame: 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 outcomes

  1. Subjective Effects

    Time frame: 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.

  2. Physiological and Side Effects

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Kentucky

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Oct 22, 2013
Registry last updated
Sep 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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