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OpenTrials
Completed

NCT Number: NCT01822132

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University, Portland, Oregon, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extended release naltrexone

Drug

Other names: Vivitrol

Placebo

Drug

Primary outcomes

  1. Discounting Tasks: Sexual Probability Discounting (SexPD)

    Time frame: 28 days post drug intervention

    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.

  2. Discounting Tasks: Standard Delay Discounting (DD)

    Time frame: 28 days post drug intervention

    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).

  3. Barrat Impulsiveness Scale (BIS)

    Time frame: 28 days post drug intervention

    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.

  4. Risk Assessment Battery (RAB)

    Time frame: 28 days post drug intervention

    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.

Secondary outcomes

  1. Methamphetamine Use

    Time frame: 28 days post drug intervention

    Participants were asked "How many days in the past 30 days did you use methamphetamine?". This is a self-report measure.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 2, 2013
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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