Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse

Sponsor

University of Kentucky (Other)

Overall Status

Completed

CT.gov ID

NCT01967381

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Methamphetamine Abuse Methamphetamine Dependence	Drug: Methamphetamine (Desoxyn®)	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Sep 1, 2018

Actual Study Completion Date :

Sep 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Arm 1 Subjects will be maintained on oral placebo.	Drug: Methamphetamine (Desoxyn®) The pharmacodynamic effects of methamphetamine (Desoxyn®) will be determined during placebo, oxazepam (Serax®), naltrexone (Revia®) and combined oxazepam and naltrexone maintenance.
Experimental: Arm 2 Subjects will be maintained on oral oxazepam (Serax®).	Drug: Methamphetamine (Desoxyn®) The pharmacodynamic effects of methamphetamine (Desoxyn®) will be determined during placebo, oxazepam (Serax®), naltrexone (Revia®) and combined oxazepam and naltrexone maintenance.
Experimental: Arm 3 Subjects will be maintained on oral naltrexone (Revia®).	Drug: Methamphetamine (Desoxyn®) The pharmacodynamic effects of methamphetamine (Desoxyn®) will be determined during placebo, oxazepam (Serax®), naltrexone (Revia®) and combined oxazepam and naltrexone maintenance.
Experimental: Arm 4 Subjects will be maintained on oral naltrexone (Revia®) and oral oxazepam (Serax®).	Drug: Methamphetamine (Desoxyn®) The pharmacodynamic effects of methamphetamine (Desoxyn®) will be determined during placebo, oxazepam (Serax®), naltrexone (Revia®) and combined oxazepam and naltrexone maintenance.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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®)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky Medical Center	Lexington	Kentucky	United States	40536

Sponsors and Collaborators

University of Kentucky
National Institute on Drug Abuse (NIDA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Craig Rush, Professor, University of Kentucky

ClinicalTrials.gov Identifier:

NCT01967381

Other Study ID Numbers:

R01DA033394

First Posted:

Oct 22, 2013

Last Update Posted:

Sep 14, 2018

Last Verified:

Sep 1, 2018

Additional relevant MeSH terms:

Methamphetamine

Study Results

No Results Posted as of Sep 14, 2018