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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DA033182-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended release naltrexone | Experimental | One dose of intramuscular injection of 380mg extended-release naltrexone. |
|
| Placebo | Placebo Comparator | One dose of intramuscular injection of placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended release naltrexone | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Methamphetamine Use | Participants were asked "How many days in the past 30 days did you use methamphetamine?". This is a self-report measure. | 28 days post drug intervention |
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Summary Inclusion Criteria:
Summary Exclusion Criteria:
The research is conducted in Portland, OR.
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| Name | Affiliation | Role |
|---|---|---|
| Philip T Korthuis, MD, MPH | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States | ||
| Portland VA Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31551824 | Derived | 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. | |
| 30266003 | 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. |
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After consenting, 13 participants did not meet screening inclusion criteria and were removed from the study and 11 participants withdrew, leaving 52 eligible participants for randomization into a treatment group (Naltrexone or Placebo)
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| ID | Title | Description |
|---|---|---|
| FG000 | Naltrexone | One dose of intramuscular injection of 380mg extended-release naltrexone. |
| FG001 | Placebo | One dose of intramuscular injection of placebo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Extended Release Naltrexone | One dose of intramuscular injection of 380mg extended-release naltrexone. Extended release naltrexone |
| BG001 | Placebo | One dose of intramuscular injection of placebo. Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Subjects with methamphetamine dependence and either HIV positive or not, all abstaining from opioids for at least 30 days. | Posted | Mean | Standard Deviation | natural log | 28 days post drug intervention |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Extended Release Naltrexone | One dose of intramuscular injection of 380mg extended-release naltrexone. Extended release naltrexone |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Todd Korthuis | Oregon Health & Science University | 503-494-8044 | korthuis@ohsu.edu |
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| ID | Term |
|---|---|
| C000624616 | vivitrol |
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| Drug |
|
| 28 days post drug intervention |
| Portland |
| Oregon |
| 97239 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| OG001 | Placebo | Participants who were randomized to receive placebo. |
|
|
| Primary | 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). | Subjects with methamphetamine dependence and either HIV positive or not, all abstaining from opioids for at least 30 days. | Posted | Mean | Standard Deviation | natural log | 28 days post drug intervention |
|
|
|
| Primary | 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. | Subjects with methamphetamine dependence and either HIV positive or not, all abstaining from opioids for at least 30 days. | Posted | Mean | Standard Deviation | score on a scale | 28 days post drug intervention |
|
|
|
| Primary | 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. | Subjects with methamphetamine dependence and either HIV positive or not, all abstaining from opioids for at least 30 days. | Posted | Mean | Standard Deviation | score on a scale | 28 days post drug intervention |
|
|
|
| Secondary | Methamphetamine Use | Participants were asked "How many days in the past 30 days did you use methamphetamine?". This is a self-report measure. | Subjects with methamphetamine dependence and either HIV positive or not, all abstaining from opioids for at least 30 days. | Posted | Mean | Standard Deviation | days | 28 days post drug intervention |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Placebo | One dose of intramuscular injection of placebo. Placebo | 0 | 27 | 0 | 27 |
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| Post_HIV-positive |
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| Post_HIV-negative |
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| Post_All |
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| Post_HIV-positive |
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| Post_HIV-negative |
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| DrugRisk_Post_All |
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| SexRisk_Baseline_All |
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| SexRisk_Post_All |
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| TotalRisk_Baseline_All |
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| TotalRisk_Post_All |
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| DrugRisk_Baseline_HIV-positive |
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| DrugRisk_Post_HIV-positive |
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| SexRisk_Baseline_HIV-positive |
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| SexRisk_Post_HIV-positive |
|
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| TotalRisk_Baseline_HIV-positive |
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| TotalRisk_Post_HIV-positive |
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| DrugRisk_Baseline_HIV-negative |
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| DrugRisk_Post_HIV-negative |
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| SexRisk_Baseline_HIV-negative |
|
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| SexRisk_Post_HIV-negative |
|
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| TotalRisk_Baseline_HIV-negative |
|
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| TotalRisk_Post_HIV-negative |
|
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| Post_HIV-negative |
|