Feedback, PsychologicalNCT03037476
Personalized Health Assessment Related to Medications (Project PHARM)
A study testing Web-based PFI and Assessment Only in people with Feedback, Psychological and Clinical Trial, run by University of Washington at 1 site in United States.
Trial summary
This research will adapt an evidence based intervention for alcohol and other drugs and evaluate its efficacy on Prescription Stimulant Medication (PSM) misuse in a web-based format for use with college students who have misused PSMs. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Feedback, Psychological, Clinical Trial, Substance Abuse
- What is being tested?
- Web-based PFI and Assessment Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 843 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2017to 15 Dec 2021
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study 1 Inclusion Criteria:
- Provides consent to participate
- Currently enrolled as a student at one of the participating campuses
- Between 18-25 year olds
- Misuse of prescription stimulants in the past year
Study 1 Exclusion Criteria:
- There are no exclusion criteria other than not meeting inclusion criteria.
Study 2 Inclusion Criteria:
- Provides consent to participate
- Currently enrolled as a student at one of the participating campuses and in their second semester/quarter or later
- Has an anticipated graduation date at least 12 months into the future
- Between 18-25 year olds
- Misuse of prescription stimulants in the past year
Study 2 Exclusion Criteria:
- There are no exclusion criteria other than not meeting inclusion criteria.
Study 3 Inclusion Criteria:
- Provides consent to participate
- Previous participation as a Study 2 participant.
Study 3 Exclusion Criteria:
- There are no exclusion criteria other than not meeting inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
This research will adapt an evidence based intervention for alcohol and other drugs and evaluate its efficacy on Prescription Stimulant Medication (PSM) misuse in a web-based format for use with college students who have misused PSMs.
Read the detailed description
This project proposes to evaluate the efficacy of Screening and Brief Interventions (SBIs) for reducing college students' PSM misuse through two different routes of screening and intervention across 9 colleges and universities spanning the United States. The research will consist of studies designed to 1) conduct focus groups to refine feedback materials (Study 1); 2) Conduct screening through the Registrar's student lists and implement a randomized controlled trial (RCT) of a web-based PSM intervention at all sites (Study 2); and 3) Evaluate the impact of the COVID-19 pandemic using the Study 2 sample on non-medical use of prescription stimulants, prescription opiates, alcohol use, marijuana use, and other substances during the COVID-19 pandemic, and understand motives, access, mental health impacts, and college student and young adult experiences during this unprecedented 12 months.
Study 1 consists of conducting up to 5 focus groups of 8-12 people to elicit feedback regarding the Personalized Feedback Tool and make refinements prior to carrying out Study 2.
In Study 2, students from 9 college campuses are screened for past year PSM misuse. Those meeting study criteria are invited to complete a web-based baseline survey and are randomized to either receive the web-based personalized feedback intervention (PFI) or to assessment only control. Participants complete follow-up assessments at 6 and 12 months post-baseline to evaluate intervention efficacy. The investigators hypothesize that participants who receive the PFI will reduce PSM misuse assessed at 6 and 12 month follow-ups. The investigators further expect reductions in perceived benefits of PSM and perceived descriptive norms for PSM, and increases in use of alternative behaviors to support academic success, and expect these changes will mediate impacts on PSM use at follow-ups. Secondary effects of the intervention on alcohol and marijuana use are also anticipated, and these reductions are expected to partially mediate PSM outcomes. Finally, PSM motives and demographics as potential moderators of intervention efficacy will also be explored.
Lastly, in February of 2021, we received approval to modify the aims for Study 3 to evaluate the impact of the COVID-19 pandemic using the Study 2 sample. In an already consented, recruited, and well-characterized sample of high-risk young adults reporting poly-substance use (Study 2 participants, n=843), Study 3 aimed to describe changes in non-medical use of prescription stimulants, prescription opiates, alcohol use, marijuana use, and other substances during the COVID-19 pandemic, and understand motives, access, mental health impacts, and college student and young adult experiences during this unprecedented 12 months. Specifically, we intend to evaluate changes pre- and post-pandemic in non-medical use of PSM, non-medical use of prescription opioid medications (POM), alcohol use, and marijuana use, as well as mood utilizing Study 2 baseline and follow-up data, controlling for intervention condition and time since last assessment. We also will evaluate student status and living arrangement as moderators. The investigators hypothesize: (1) Young adults will report less PSM and less POM during the pandemic compared to pre-pandemic assessments, in part due to reduced ease of access and a change in motives for use; (2) Given previous findings that academic motives were 8 of the 9 most frequently endorsed reasons for PSM, and given perceptions that a move to virtual learning has been less academically challenging, we hypothesize that academic motives for PSM will decrease significantly during the pandemic compared to pre-pandemic; (3) Those no longer in school will report less PSM and less POM during the pandemic compared to pre-pandemic. (4) Those living at home will have decreased alcohol and marijuana use compared to pre-pandemic. Among those reporting current student status at the time of the new survey, we will be able to evaluate changes in motives for use, access, and academic pressure from baseline to present.
- Conditions
- Feedback, Psychological, Clinical Trial, Substance Abuse
- Being tested
- Web-based PFI, Assessment Only
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based PFIBehavioural
A web-based 5 component Personalized Feedback Tool covering content on: 1) Stimulants, 2) Marijuana, 3) PSM and unwanted effects, 4) Academics, and 5) Alcohol.
Assessment OnlyBehavioural
The Assessment Only condition receives assessment on substance use, health behaviors, and academic behaviors at baseline, 6 month follow-up, and 12 month follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Web-Based PFI | Experimental | Participants randomized to the web-based PFI in Study 2 receive a 5 component Personalized Feedback Tool. The first component is presented immediately after the baseline survey and a link to each of the remaining 4 components is sent to participants spaced 1 to 2 weeks apart. The PFI components cover: 1) Stimulants, 2) Marijuana, 3) PSM and unwanted effects, 4) Academics, and 5) Alcohol. Each component is comprised of personalized feedback presented in text and graphic format, and each component includes links to tips for making changes if and when the participant is contemplating or ready to commit to change. These tips include general relapse prevention strategies, as well as information about the importance of regular class attendance, study habits, and sleep habits for academic success. General educational tips/strategies for time management, as well as tips for initiating behavior change are also included. Each component takes approximately 5-10 minutes to review. Receives: Behavioral: Web-based PFI |
| Assessment Only | Other | The Assessment Only group receives assessment on substance use, health behaviors, and academic behaviors at baseline, 6-month follow-up, and 12-month follow-up in Study 2. Receives: Behavioral: Assessment Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Past 6 Month Non-Medical Use of Prescription Stimulant Medication Frequency
Assesses frequency of non-medical use of prescription stimulant medications. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline).
Measured: Baseline and 6 months, Baseline and 12 months
Change in Past 6 Month Medical Misuse of Prescription Stimulant Medication
Assesses past 6 month medical misuse of prescription stimulant medication. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline).
Measured: Baseline and 6 months, Baseline and 12 months
Change in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)
Assesses problematic use of tobacco, alcohol, prescription, and illicit drugs over the past year and 3 months. Response options included: 0= Never, 1= Less than Monthly, 2= Monthly, 3= Weekly, 4= Daily or Almost Daily. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline).
Measured: Baseline and 6 months, Baseline and 12 months
Change in Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Stimulants Only
Measures past 3 month non-medical use of prescription stimulants and associated negative consequences. Items were summed to create a scale summary score where higher values indicated more problematic use in the past 3 months (min=0, max=40). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline).
Measured: Baseline and 6 months, Baseline and 12 months
Change in Past 6 Month Prescription Stimulant Use Consequence Questionnaire
Assesses negative consequences associated with prescription stimulant misuse over the previous 6 months. A score of "0" indicates that a given consequence did not occur and a score of "1" indicates that it did occur. Items were summed to create a scale summary score of overall number of unique consequences that occurred in the past 6 months (min=0, max=19). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline).
Measured: 6 and 12 month follow-up
Secondary outcomes (7)
Change in Peak Quantity of Alcohol Consumed in Past Month
Assesses quantity in standard drinks of peak drinking episode of alcohol consumption over the past month. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline).
Measured: Baseline and 6 months, Baseline and 12 months
Change in Past 6 Month Daily Drinking Questionnaire
Assesses typical alcohol consumption over the course of a typical week. Responses for number of drinks consumed each day of a typical week were summed to create a summary score of total number of drinks consumed over a typical week. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline).
Measured: Baseline and 6 months, Baseline and 12 months
Change in Past 6 Month Rutgers Alcohol Problem Index
Measures negative alcohol-related consequences experienced over the past 6 months. A score of "0" indicates that a given consequence did not occur and a score of "1" indicates that it did occur. Items were summed to create a scale summary score of overall number of unique consequences that occurred in the past 6 months (min=0, max=26). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline).
Measured: Baseline and 6 months, Baseline and 12 months
Change in Past Year, 6 Month, and 30 Day Marijuana Use Frequency
Items measure typical frequency of marijuana use and number of days used in the past year, 6 months, and 30 days. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline).
Measured: Baseline and 6 months, Baseline and 12 months
Change in Past 6 Month Rutgers Marijuana Problem Index
Measures negative marijuana-related consequences experienced over the past 6 months. A score of "0" indicates that a given consequence did not occur and a score of "1" indicates that it did occur. Items were summed to create a scale summary score of overall number of unique consequences that occurred in the past 6 months (min=0, max=26). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline).
Measured: Baseline and 6 months, Baseline and 12 months
Change in Frequency of Past Month Alcohol Consumption
Assesses frequency (days) of alcohol consumption over the past month (min=0, max=31). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline).
Measured: Baseline and 6 months, Baseline and 12 months
Change in Typical Quantity in Standard Drinks Consumed on a Typical Occasion in the Past Month
Assesses typical drinking quantity in standard drinks of alcohol consumed during a typical drinking occasion over the past month. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline).
Measured: Baseline and 6 months, Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start30 Mar 2017
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
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.
- Other trials for Feedback, PsychologicalStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 843 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Jason Kilmer, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037476
- Sponsor's protocol ID
- STUDY00001782
- Other IDs
- 3U01DA040219-04S1
- Status last verified
- Jul 2023
- First submitted
- 5 Jan 2017
- Last updated
- 1 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Health Assessment Related to Medications (Project PHARM)
- ClinicalTrials.gov ID
- NCT03037476
- Acronym / sponsor ID
- STUDY00001782
- Conditions
- Feedback, Psychological, Clinical Trial, Substance Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 843 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Posted 1 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research will adapt an evidence based intervention for alcohol and other drugs and evaluate its efficacy on Prescription Stimulant Medication (PSM) misuse in a web-based format for use with college students who have misused PSMs.
Detailed description
This project proposes to evaluate the efficacy of Screening and Brief Interventions (SBIs) for reducing college students' PSM misuse through two different routes of screening and intervention across 9 colleges and universities spanning the United States. The research will consist of studies designed to 1) conduct focus groups to refine feedback materials (Study 1); 2) Conduct screening through the Registrar's student lists and implement a randomized controlled trial (RCT) of a web-based PSM intervention at all sites (Study 2); and 3) Evaluate the impact of the COVID-19 pandemic using the Study 2 sample on non-medical use of prescription stimulants, prescription opiates, alcohol use, marijuana use, and other substances during the COVID-19 pandemic, and understand motives, access, mental health impacts, and college student and young adult experiences during this unprecedented 12 months.
Study 1 consists of conducting up to 5 focus groups of 8-12 people to elicit feedback regarding the Personalized Feedback Tool and make refinements prior to carrying out Study 2.
In Study 2, students from 9 college campuses are screened for past year PSM misuse. Those meeting study criteria are invited to complete a web-based baseline survey and are randomized to either receive the web-based personalized feedback intervention (PFI) or to assessment only control. Participants complete follow-up assessments at 6 and 12 months post-baseline to evaluate intervention efficacy. The investigators hypothesize that participants who receive the PFI will reduce PSM misuse assessed at 6 and 12 month follow-ups. The investigators further expect reductions in perceived benefits of PSM and perceived descriptive norms for PSM, and increases in use of alternative behaviors to support academic success, and expect these changes will mediate impacts on PSM use at follow-ups. Secondary effects of the intervention on alcohol and marijuana use are also anticipated, and these reductions are expected to partially mediate PSM outcomes. Finally, PSM motives and demographics as potential moderators of intervention efficacy will also be explored.
Lastly, in February of 2021, we received approval to modify the aims for Study 3 to evaluate the impact of the COVID-19 pandemic using the Study 2 sample. In an already consented, recruited, and well-characterized sample of high-risk young adults reporting poly-substance use (Study 2 participants, n=843), Study 3 aimed to describe changes in non-medical use of prescription stimulants, prescription opiates, alcohol use, marijuana use, and other substances during the COVID-19 pandemic, and understand motives, access, mental health impacts, and college student and young adult experiences during this unprecedented 12 months. Specifically, we intend to evaluate changes pre- and post-pandemic in non-medical use of PSM, non-medical use of prescription opioid medications (POM), alcohol use, and marijuana use, as well as mood utilizing Study 2 baseline and follow-up data, controlling for intervention condition and time since last assessment. We also will evaluate student status and living arrangement as moderators. The investigators hypothesize: (1) Young adults will report less PSM and less POM during the pandemic compared to pre-pandemic assessments, in part due to reduced ease of access and a change in motives for use; (2) Given previous findings that academic motives were 8 of the 9 most frequently endorsed reasons for PSM, and given perceptions that a move to virtual learning has been less academically challenging, we hypothesize that academic motives for PSM will decrease significantly during the pandemic compared to pre-pandemic; (3) Those no longer in school will report less PSM and less POM during the pandemic compared to pre-pandemic. (4) Those living at home will have decreased alcohol and marijuana use compared to pre-pandemic. Among those reporting current student status at the time of the new survey, we will be able to evaluate changes in motives for use, access, and academic pressure from baseline to present.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-Based PFI | Experimental | Behavioral: Web-based PFIParticipants randomized to the web-based PFI in Study 2 receive a 5 component Personalized Feedback Tool. The first component is presented immediately after the baseline survey and a link to each of the remaining 4 components is sent to participants spaced 1 to 2 weeks apart. The PFI components cover: 1) Stimulants, 2) Marijuana, 3) PSM and unwanted effects, 4) Academics, and 5) Alcohol. Each component is comprised of personalized feedback presented in text and graphic format, and each component includes links to tips for making changes if and when the participant is contemplating or ready to commit to change. These tips include general relapse prevention strategies, as well as information about the importance of regular class attendance, study habits, and sleep habits for academic success. General educational tips/strategies for time management, as well as tips for initiating behavior change are also included. Each component takes approximately 5-10 minutes to review. |
| Assessment Only | Other | Behavioral: Assessment OnlyThe Assessment Only group receives assessment on substance use, health behaviors, and academic behaviors at baseline, 6-month follow-up, and 12-month follow-up in Study 2. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- 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 |
|---|---|---|
| Web-based PFIA web-based 5 component Personalized Feedback Tool covering content on: 1) Stimulants, 2) Marijuana, 3) PSM and unwanted effects, 4) Academics, and 5) Alcohol. | Behavioural | Web-Based PFI |
| Assessment OnlyThe Assessment Only condition receives assessment on substance use, health behaviors, and academic behaviors at baseline, 6 month follow-up, and 12 month follow-up. | Behavioural | Assessment Only |
Primary outcome
Change in Past 6 Month Non-Medical Use of Prescription Stimulant Medication Frequency
Time frame: Baseline and 6 months, Baseline and 12 months
Assesses frequency of non-medical use of prescription stimulant medications. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline).
Change in Past 6 Month Medical Misuse of Prescription Stimulant Medication
Time frame: Baseline and 6 months, Baseline and 12 months
Assesses past 6 month medical misuse of prescription stimulant medication. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline).
Change in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)
Time frame: Baseline and 6 months, Baseline and 12 months
Assesses problematic use of tobacco, alcohol, prescription, and illicit drugs over the past year and 3 months. Response options included: 0= Never, 1= Less than Monthly, 2= Monthly, 3= Weekly, 4= Daily or Almost Daily. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline).
Change in Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Stimulants Only
Time frame: Baseline and 6 months, Baseline and 12 months
Measures past 3 month non-medical use of prescription stimulants and associated negative consequences. Items were summed to create a scale summary score where higher values indicated more problematic use in the past 3 months (min=0, max=40). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline).
Change in Past 6 Month Prescription Stimulant Use Consequence Questionnaire
Time frame: 6 and 12 month follow-up
Assesses negative consequences associated with prescription stimulant misuse over the previous 6 months. A score of "0" indicates that a given consequence did not occur and a score of "1" indicates that it did occur. Items were summed to create a scale summary score of overall number of unique consequences that occurred in the past 6 months (min=0, max=19). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline).
7 secondary outcomes
Change in Peak Quantity of Alcohol Consumed in Past Month
Time frame: Baseline and 6 months, Baseline and 12 months
Change in Past 6 Month Daily Drinking Questionnaire
Time frame: Baseline and 6 months, Baseline and 12 months
Change in Past 6 Month Rutgers Alcohol Problem Index
Time frame: Baseline and 6 months, Baseline and 12 months
Change in Past Year, 6 Month, and 30 Day Marijuana Use Frequency
Time frame: Baseline and 6 months, Baseline and 12 months
Change in Past 6 Month Rutgers Marijuana Problem Index
Time frame: Baseline and 6 months, Baseline and 12 months
Change in Frequency of Past Month Alcohol Consumption
Time frame: Baseline and 6 months, Baseline and 12 months
Change in Typical Quantity in Standard Drinks Consumed on a Typical Occasion in the Past Month
Time frame: Baseline and 6 months, Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based PFI and Assessment Only in people with Feedback, Psychological and Clinical Trial, run by University of Washington at 1 site 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 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 1 Aug 2023). 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?
Change in Past 6 Month Non-Medical Use of Prescription Stimulant Medication Frequency (time frame: Baseline and 6 months, Baseline and 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2023.