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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01822132
First Posted: April 2, 2013
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
P. Todd Korthuis, Oregon Health and Science University
March 21, 2013
April 2, 2013
October 18, 2017
May 2013
March 2015   (Final data collection date for primary outcome measure)
Discounting Tasks [ Time Frame: 28 days ]
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.
Complete list of historical versions of study NCT01822132 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
Not Provided
Not Provided
 
Risky Decision Making in Methamphetamine Users: The Role of Opioid Blockade
Risky Decision Making in Methamphetamine Users: The Role of Opioid Blockade

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
  • Methamphetamine Abuse
  • HIV
  • Drug: Extended release naltrexone
    Other Name: Vivitrol
  • Drug: Placebo
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
March 2015
March 2015   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01822132
ALKIIT-KOR-034
1R21DA033182-01A1 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
P. Todd Korthuis, Oregon Health and Science University
Oregon Health and Science University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Philip T Korthuis, MD, MPH Oregon Health and Science University
Oregon Health and Science University
April 2015

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