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

Tracking Information
First Submitted Date ICMJE	March 21, 2013
First Posted Date ICMJE	April 2, 2013
Last Update Posted Date	April 28, 2015
Study Start Date ICMJE	May 2013
Actual Primary Completion Date	March 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 24, 2014)	Discounting Tasks [ Time Frame: 28 days ]
Original Primary Outcome Measures ICMJE; (submitted: March 27, 2013)	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; (submitted: April 24, 2014)	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; (submitted: March 27, 2013)	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 Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (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
Actual Enrollment ICMJE; (submitted: April 24, 2015)	62
Original Estimated Enrollment ICMJE; (submitted: March 27, 2013)	50
Actual Study Completion Date	March 2015
Actual 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	No
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 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	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