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

NCT01822132 | Completed Results

• 2 other identifiers: ALKIIT-KOR-0341R21DA033182-01A1
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

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.

Conditions

Methamphetamine Abuse; HIV

Outcome Measures

Primary Outcomes (4)

• Discounting Tasks: Sexual Probability Discounting (SexPD)

  In the SexPD task, subjects are asked to choose between having sex with a more appealing partner with a varying chance of having a sexually transmitted infection (STI) or a less appealing partner with no STI. A hyperbolic decay model was used to calculate h, a free parameter that indexes the rate of probabilistic discounting. Smaller h values indicate a preference for probabilistic (i.e., riskier) outcomes. To normalize the data, the natural log of h values were calculated and reported here.

  28 days post drug intervention

• Discounting Tasks: Standard Delay Discounting (DD)

  Monetary delay discounting task consisted of choosing between a larger, delayed and a smaller, immediate reward. A hyperbolic decay model was used to calculate k, a free parameter that indexes the rate of delay discounting. As k values are typically skewed across subjects, the distribution of k was normalized by using a natural log transformation. The normalized values are reported here. If k typically ranges between 0.5 and 10\^-5, then the natural log of k will range between -0.69 and -11.5. Larger normalized k values indicate a preference for smaller sooner outcomes (i.e., more impulsive decision-making).

  28 days post drug intervention

• Barrat Impulsiveness Scale (BIS)

  The Barrat Impulsiveness Scale (BIS) is a 30 item questionnaire to measure a persons impulsiveness. Items are answered on a 4-point scale and scored 1-4 then summed across responses. Total scores range from 30-120 with a higher summed score indicating higher impulsivity.

  28 days post drug intervention

• Risk Assessment Battery (RAB)

  The Risk Assessment Battery (RAB) is a 26 question self-administered assessment focusing on drug use, injection and sexual risk during the past 30 days. Three composite HIV risk scores (drug, sex, and total score) are calculated. The questions have different numbers of items, and scores for a single question can range from 0 to 7, with higher values reflecting more instances of risk behavior. The drug risk score has a range of 0 to 22 and is calculated from 8 questions that address recent substance use, including frequency, needle sharing, and cleaning of the "works." 9 questions are used to calculate a sex risk score that has a range of 0 to 18, and these questions address the frequency and types of sexual behavior, HIV status of sexual partners, and type of protection that was used (if any). Total score is calculated by adding drug and sex scores and dividing by 40, the maximum score possible, and ranges from 0 to 40 where higher scores indicate greater risk behavior.

  28 days post drug intervention

Secondary Outcomes (1)

• Methamphetamine Use

  28 days post drug intervention

Study Arms (2)

Extended release naltrexone

EXPERIMENTAL

One dose of intramuscular injection of 380mg extended-release naltrexone.

Drug: Extended release naltrexone

Placebo

PLACEBO COMPARATOR

One dose of intramuscular injection of placebo.

Drug: Placebo

Interventions

Extended release naltrexone DRUG

Also known as: Vivitrol

Extended release naltrexone

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnostic and Statistical Manual (DSM)-IV Methamphetamine Dependence
• Deemed healthy enough to participate by study physician
• Age 18-55
• Right handed
• English-speaking

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Portland VA Medical Center

Portland, Oregon, 97239, United States

Location

Related Publications (2)

• Kohno M, Morales AM, Dennis LE, McCready H, Hoffman WF, Korthuis PT. Effects of Naltrexone on Large-Scale Network Interactions in Methamphetamine Use Disorder. Front Psychiatry. 2019 Sep 3;10:603. doi: 10.3389/fpsyt.2019.00603. eCollection 2019.

  PMID: 31551824 DERIVED

• Kohno M, Dennis LE, McCready H, Schwartz DL, Hoffman WF, Korthuis PT. A preliminary randomized clinical trial of naltrexone reduces striatal resting state functional connectivity in people with methamphetamine use disorder. Drug Alcohol Depend. 2018 Nov 1;192:186-192. doi: 10.1016/j.drugalcdep.2018.07.045. Epub 2018 Sep 21.

  PMID: 30266003 DERIVED

MeSH Terms

Interventions

vivitrol

Results Point of Contact

• Title: Dr. Todd Korthuis
• Organization: Oregon Health & Science University

korthuis@ohsu.edu

503-494-8044

Study Officials

• Philip T Korthuis, MD, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: April 2, 2013
• Study Start: May 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 5, 2019
• Results First Posted: February 6, 2019

Record last verified: 2019-02

Locations

US (2)