Methamphetamine AbuseNCT01822132
Risky Decision Making in Methamphetamine Users: The Role of Opioid Blockade
A study testing Extended release naltrexone in people with Methamphetamine Abuse and HIV, run by Oregon Health and Science University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Methamphetamine Abuse, HIV
- What is being tested?
- Extended release naltrexone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oregon Health & Science University
Portland, Oregon, 97239
Portland VA Medical Center
Portland, Oregon, 97239
About this study
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
- Being tested
- Extended release naltrexone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended release naltrexoneDrug
Also called Vivitrol
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Extended release naltrexone | Experimental | One dose of intramuscular injection of 380mg extended-release naltrexone. Receives: Drug: Extended release naltrexone |
| Placebo | Placebo comparator | One dose of intramuscular injection of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 28 days post drug intervention
Secondary outcomes (1)
Methamphetamine Use
Participants were asked "How many days in the past 30 days did you use methamphetamine?". This is a self-report measure.
Measured: 28 days post drug intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Methamphetamine AbuseStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, P. Todd Korthuis, MD, Oregon Health and Science University
- Investigators
- Philip T Korthuis, MD, MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822132
- Sponsor's protocol ID
- ALKIIT-KOR-034
- Other IDs
- 1R21DA033182-01A1
- Status last verified
- Feb 2019
- First submitted
- 21 Mar 2013
- Last updated
- 5 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 31551824Kohno 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.
PubMed 30266003
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risky Decision Making in Methamphetamine Users: The Role of Opioid Blockade
- ClinicalTrials.gov ID
- NCT01822132
- Acronym / sponsor ID
- ALKIIT-KOR-034
- Conditions
- Methamphetamine Abuse, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- May 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Posted 6 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended release naltrexone | Experimental | Drug: Extended release naltrexoneOne dose of intramuscular injection of 380mg extended-release naltrexone. |
| Placebo | Placebo comparator | Drug: PlaceboOne dose of intramuscular injection of placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended release naltrexoneAlso: Vivitrol | Drug | Extended release naltrexone |
| Placebo | Drug | Placebo |
Primary outcome
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.
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).
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.
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.
1 secondary outcome
Methamphetamine Use
Time frame: 28 days post drug intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31551824Kohno 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.
- Derived from this study: PubMed 30266003Kohno 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip T Korthuis, MD, MPH principal investigator
Oregon Health and Science University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended release naltrexone in people with Methamphetamine Abuse and HIV, run by Oregon Health and Science University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discounting Tasks: Sexual Probability Discounting (SexPD) (time frame: 28 days post drug intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01822132, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.