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:
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
  Purpose

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.


Condition Intervention
Methamphetamine Abuse
HIV
Drug: Extended release naltrexone
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Risky Decision Making in Methamphetamine Users: The Role of Opioid Blockade

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Discounting Tasks [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: May 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extended release naltrexone
One dose of intramuscular injection of 380mg extended-release naltrexone.
Drug: Extended release naltrexone
Other Name: Vivitrol
Placebo Comparator: Placebo
One dose of intramuscular injection of placebo.
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01822132

Contacts
Contact: Sarann Bielavitz, BS 503-418-1944 bielavit@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Philip T Korthuis, MD, MPH         
Portland VA Medical Center Recruiting
Portland, Oregon, United States, 97239
Sub-Investigator: Willliam Hoffman, PhD, MD         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Philip T Korthuis, MD, MPH Oregon Health and Science University
  More Information

No publications provided

Responsible Party: P. Todd Korthuis, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01822132     History of Changes
Other Study ID Numbers: ALKIIT-KOR-034, 1R21DA033182-01A1
Study First Received: March 21, 2013
Last Updated: April 24, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Naltrexone
Methamphetamine
Analgesics, Opioid
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Stimulants
Sympathomimetics
Autonomic Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Narcotics
Central Nervous System Depressants
Analgesics

ClinicalTrials.gov processed this record on August 27, 2014