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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Oregon Health and Science University
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, 2014
Last verified: April 2014
History of Changes

March 21, 2013
April 24, 2014
May 2013
January 2015   (final data collection date for primary outcome measure)
Discounting Tasks [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Discounting Tasks [ Time Frame: 28 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Methamphetamine use [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • HIV risk behaviors [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Antiretroviral adherence [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Neural Mapping [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Unprotected sex or sharing of needles/works in the 28 days since injection of study drug or placebo.
  • Antiretroviral adherence [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
 
Recruiting
50
January 2015
January 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.
Both
18 Years to 55 Years
No
Contact: Sarann Bielavitz, BS 503-418-1944 bielavit@ohsu.edu
United States
 
NCT01822132
ALKIIT-KOR-034, 1R21DA033182-01A1
No
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 2014

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