Risky Decision Making in Methamphetamine Users: The Role of Opioid Blockade

NCT ID: NCT01822132

Last Updated: 2019-03-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-03-31

Brief Summary

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The purpose of this protocol is to learn more about impulsive decision making in people who use methamphetamines. The investigators would like to know if a medication called naltrexone changes how people make decisions. The investigators would also like to know whether changes in decision making can be observed by MRI (magnetic resonance imaging).

The research is conducted in Portland, OR.

Detailed Description

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Conditions

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Methamphetamine Abuse HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Extended release naltrexone

One dose of intramuscular injection of 380mg extended-release naltrexone.

Group Type EXPERIMENTAL

Extended release naltrexone

Intervention Type DRUG

Placebo

One dose of intramuscular injection of placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Extended release naltrexone

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Vivitrol

Eligibility Criteria

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Inclusion Criteria

* Diagnostic and Statistical Manual (DSM)-IV Methamphetamine Dependence
* Deemed healthy enough to participate by study physician
* Age 18-55
* Right handed
* English-speaking

Exclusion Criteria

* Current opioid use in the last 30 days; opioid abuse or dependence within past 5 years
* Pregnancy
* MRI contraindications (e.g. metal in head).

The research is conducted in Portland, OR.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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P. Todd Korthuis, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philip T Korthuis, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Portland VA Medical Center

Portland, Oregon, United States

Site Status

Countries

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United States

References

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Kohno M, Morales AM, Dennis LE, McCready H, Hoffman WF, Korthuis PT. Effects of Naltrexone on Large-Scale Network Interactions in Methamphetamine Use Disorder. Front Psychiatry. 2019 Sep 3;10:603. doi: 10.3389/fpsyt.2019.00603. eCollection 2019.

Reference Type DERIVED
PMID: 31551824 (View on PubMed)

Kohno M, Dennis LE, McCready H, Schwartz DL, Hoffman WF, Korthuis PT. A preliminary randomized clinical trial of naltrexone reduces striatal resting state functional connectivity in people with methamphetamine use disorder. Drug Alcohol Depend. 2018 Nov 1;192:186-192. doi: 10.1016/j.drugalcdep.2018.07.045. Epub 2018 Sep 21.

Reference Type DERIVED
PMID: 30266003 (View on PubMed)

Other Identifiers

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1R21DA033182-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ALKIIT-KOR-034

Identifier Type: -

Identifier Source: org_study_id

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