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

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ClinicalTrials.gov Identifier: NCT01822132
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : April 28, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Methamphetamine Abuse HIV Drug: Extended release naltrexone Drug: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
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
Study Start Date : May 2013
Primary Completion Date : March 2015
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Secondary Outcome Measures :
  1. Neural Mapping [ Time Frame: 28 days ]
  2. Methamphetamine use [ Time Frame: 28 days ]
  3. HIV risk behaviors [ Time Frame: 28 days ]
  4. Antiretroviral adherence [ Time Frame: 28 days ]

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: April 2, 2013    Key Record Dates
Last Update Posted: April 28, 2015
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