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

This study has been completed.

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

P. Todd Korthuis, Oregon Health and Science University

ClinicalTrials.gov Identifier:

NCT01822132

First received: March 21, 2013

Last updated: April 24, 2015

Last verified: April 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

March 21, 2013

Last Updated Date

April 24, 2015

Start Date ^ICMJE

May 2013

Primary Completion Date

March 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Discounting Tasks [ Time Frame: 28 days ]

Original Primary Outcome Measures ^ICMJE

Discounting Tasks [ Time Frame: 28 days ]

Delay Discounting economic task that asks subjects to choose between an immediate reward and a second reward that varies in delay until receipt. Probes the neural mechanism of the effect of endogenous opioid blockade on impulsive choice in MA users.

Change History

Complete list of historical versions of study NCT01822132 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Neural Mapping [ Time Frame: 28 days ]
Methamphetamine use [ Time Frame: 28 days ]
HIV risk behaviors [ Time Frame: 28 days ]
Antiretroviral adherence [ Time Frame: 28 days ]

Original Secondary Outcome Measures ^ICMJE

Neural Mapping [ Time Frame: 28 days ]
We expect to identify a map of regions for each component of delay discounting: delay magnitude, reward magnitude and choice. Our preliminary assignment of delay sensitivity to middle frontal gyrus may reflect magnitude sensitivity. This would suggest that discounting (calculation of the value of a delayed reward) is a separate cognitive function from representation of the magnitude of the alternative reward. We expect increased ventrolateral prefrontal and ventral striatal activity with increased immediate reward magnitude in the overall group. We expect increased medial prefrontal activity to scale with decreased delay magnitude, and for dorsal regions (inferior parietal lobule, insula, and dorsolateral prefrontal cortex) to exhibit more activity in Decision trials than No Decision trials.
Methamphetamine use [ Time Frame: 28 days ]
Any methamphetamine use in the 28 days since injection of study drug or placebo, by self report and urine drug screen.
HIV risk behaviors [ Time Frame: 28 days ]
Unprotected sex or sharing of needles/works in the 28 days since injection of study drug or placebo.
Antiretroviral adherence [ Time Frame: 28 days ]
Any missed doses of antiretroviral medications in 28 days since injection of study drug or placebo, by self-report.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)

Condition ^ICMJE

Methamphetamine Abuse
HIV

Intervention ^ICMJE

Drug: Extended release naltrexone
Other Name: Vivitrol
Drug: Placebo

Study Arms

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

Intervention: Drug: Extended release naltrexone
Placebo Comparator: Placebo
One dose of intramuscular injection of placebo.

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2015

Primary Completion Date

March 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Summary 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

Summary 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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 55 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01822132

Other Study ID Numbers ^ICMJE

ALKIIT-KOR-034
1R21DA033182-01A1 ( US NIH Grant/Contract Award Number )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

P. Todd Korthuis, Oregon Health and Science University

Study Sponsor ^ICMJE

Oregon Health and Science University

Collaborators ^ICMJE

National Institute on Drug Abuse (NIDA)

Investigators ^ICMJE

Principal Investigator:

Philip T Korthuis, MD, MPH

Oregon Health and Science University

PRS Account

Oregon Health and Science University

Verification Date

April 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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