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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
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 P. Todd Korthuis, Oregon Health and Science University:

Primary Outcome Measures:
  • Discounting Tasks [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 62
Study Start Date: May 2013
Study Completion Date: March 2015
Primary Completion Date: March 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822132


Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Portland VA Medical Center
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Philip T Korthuis, MD, MPH Oregon Health and Science University
  More Information

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 ( U.S. NIH Grant/Contract )
First Submitted: March 21, 2013
First Posted: April 2, 2013
Last Update Posted: October 18, 2017
Last Verified: April 2015

Additional relevant MeSH terms:
Naltrexone
Methamphetamine
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Stimulants
Sympathomimetics
Autonomic Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors