Heavy DrinkingNCT07118826
A Brief Intervention for Young Adult Substance Users With Interpersonal Trauma
A study testing Standard Brief Intervention and Trauma-Informed and Peer-Supported Brief Intervention in people with Heavy Drinking and Alcohol Drinking, run by Western Kentucky University at 1 site in United States.
Trial summary
This proposal seeks to improve a mobile-based brief intervention for young adults who engage in heavy alcohol use and have experienced interpersonal trauma. The enhancement involves incorporating adaptive coping strategies to address trauma-related distress and engaging peer coaches following the intervention to… Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Heavy Drinking, Alcohol Drinking, Substance Use
- What is being tested?
- Standard Brief Intervention and Trauma-Informed and Peer-Supported Brief Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 29
- Ability to speak and understand English
- Access to a cell phone
- Lifetime history of interpersonal trauma exposure
- Heavy alcohol use
Who cannot join
- 1) Currently receiving psychological therapy or psychotropic medication for substance use.
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Kentucky University
Bowling Green, Kentucky, 42101
About this study
Official title: Evaluation and Refinement of a Trauma-Informed and Peer Supported Mobile Brief Intervention for Young Adult Substance Users With Interpersonal Trauma
This proposal seeks to improve a mobile-based brief intervention for young adults who engage in heavy alcohol use and have experienced interpersonal trauma. The enhancement involves incorporating adaptive coping strategies to address trauma-related distress and engaging peer coaches following the intervention to support sustained treatment effects. Participants will be randomly assigned to receive either the enhanced intervention with peer coaching or a standard version of the brief intervention. Follow-up assessments will be conducted at 3 and 6 months after the intervention. The research team expects that the trauma-informed and peer-supported brief intervention (TIPS-BI) will have low dropout rates, be well-received by participants, and lead to greater reductions in alcohol use than the standard brief intervention.
Read the detailed description
Alcohol is the most commonly used substance in the United States, with emerging adults (EAs) showing the highest rates of heavy use among all age groups. Persistent heavy drinking in this population is linked to a range of negative outcomes, including poor mental health, reduced life satisfaction, cognitive impairments, academic difficulties, increased risk for motor vehicle accidents, and the development of substance use disorders.
Brief interventions (BIs) for substance use typically involve one or two individual sessions that provide personalized feedback. These interventions aim to challenge inaccurate normative beliefs and emphasize personal consequences of substance use. While BIs have demonstrated success in reducing alcohol consumption and related problems in numerous clinical trials, their impact is often limited. Common challenges include small effect sizes that diminish over time and reduced effectiveness among individuals with interpersonal trauma-specifically, trauma involving human-perpetrated violence and associated emotional distress.
One explanation for these limited outcomes is that BIs are not tailored to high-risk groups such as trauma survivors. Improving BIs may require addressing two key gaps: (1) targeting coping motives-strong predictors of heavy and persistent drinking among trauma-exposed individuals that are typically not addressed in standard BIs, and (2) incorporating peer coaches to support continued gains after the intervention.
There are compelling reasons to integrate trauma content, coping strategies, and peer support into BIs for substance-using EAs. Emerging adulthood is the developmental stage with the highest risk of experiencing interpersonal trauma, which is linked to poor mental health, low social support, and elevated alcohol use. Research indicates that coping with negative emotions is a common motive for substance use in this age group-especially among trauma-exposed individuals-yet these connections are not typically addressed in standard BIs. Additionally, traditional BIs often fail to provide adaptive strategies for managing trauma-related emotional distress, despite the availability of evidence-based coping techniques.
Peer influence also plays a critical role in both initiating and maintaining substance use during emerging adulthood. Including affiliated peers in in-person BIs has improved treatment outcomes in past studies. However, few interventions have extended peer involvement to the post-intervention period, despite the demonstrated success of peer coaches in other health domains.
Further, in-person, counselor-delivered BIs have been criticized as costly and difficult to implement broadly, limiting their scalability. Since few EAs actively seek substance use prevention or treatment services, there is a pressing need for low-cost, accessible delivery methods. Given the widespread use of mobile phones, mobile-delivered BIs represent a promising approach. Early evidence suggests they can be effective with EAs, though engagement tends to be low. Incorporating peer coaches into follow-up may help address this issue and boost engagement.
The primary aim of the proposed study is to evaluate the feasibility and efficacy of a mobile-delivered, trauma-informed, and peer-supported brief intervention (TIPS-BI) for emerging adults with a history of interpersonal trauma. This study will advance the BI literature by:
- including content that links trauma to substance use and teaches emotion regulation strategies, and
- integrating trained peer coaches into the text-message follow-up phase.
A total of 190 emerging adults (ages 18-29, with 60% expected to be female) who have a history of interpersonal trauma and report recent heavy alcohol use will be enrolled in a two-arm randomized controlled trial. Participants will be assigned to one of two conditions:
Group 1: Mobile-delivered TIPS-BI with peer coach follow-up (N=95)
Group 2: Mobile-delivered standard substance use BI (N=95)
Aim 1: Assess the feasibility and acceptability of the TIPS-BI. The investigators hypothesize that the TIPS-BI will result in low dropout rates (<10%) at follow-up, comparable to the standard BI. They also expect participants to rate the TIPS-BI as satisfactory, relevant, helpful, and minimally burdensome.
Aims 2 \& 3: Evaluate the efficacy of the TIPS-BI. It is hypothesized that participants in the TIPS-BI group will show greater reductions in alcohol use and coping motives at 3- and 6-month follow-ups compared to those receiving the standard BI. Additionally, the TIPS-BI is expected to lead to greater improvements in coping self-efficacy at both follow-up time points.
- Conditions
- Heavy Drinking, Alcohol Drinking, Substance Use, Drinking Behavior
- Being tested
- Standard Brief Intervention, Trauma-Informed and Peer-Supported Brief Intervention
- Keywords
- Brief intervention, Alcohol, Trauma, Drinking, Peer coaching
- Medical subject headings
- Alcohol Drinking, Substance-Related Disorders, Drinking Behavior, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Brief InterventionBehavioural
Immediately following completion of the baseline assessment, participants will be texted a link to a secure website which contains the participant's personalized feedback. Personalized feedback is automatically presented via a programming algorithm that is based on the participants baseline survey responses. The personalized feedback component will include a personalized substance use profile, information on peer norms, prior substance-related consequences experienced by the participant, practical costs (e.g., money spent on substances, fees for a DUI), and standard protective behavioral strategies to limit substance-related risk.
Trauma-Informed and Peer-Supported Brief InterventionBehavioural
In addition to the components of the standard brief intervention, the TIPS-BI will include personalized feedback about participants use of substances to cope. Additionally, participants will be provided with psychoeducation about the link between substance use, trauma, and coping motives, and information highlighting the iatrogenic effects that substance use has on negative emotions. Participants will also be given a series of evidence-based alternative coping strategies for managing trauma-related distress such as anxiety, depression, and PTSD. Participants will be asked to set goals related to utilization of these alternative coping strategies. Participants will then be informed that a trained peer who is part of the research team will follow up with them via text message at the monthly time points to review adherence to their goals and offer support.
| Study group | Role | What they receive |
|---|---|---|
| Standard Brief Intervention | Experimental | Immediately following completion of the baseline assessment, participants will be texted a link to a secure website which contains the participant's personalized feedback. Personalized feedback is automatically presented via a programming algorithm that is based on the participants baseline survey responses. The personalized feedback component will include a personalized substance use profile, information on peer norms, prior substance-related consequences experienced by the participant, practical costs (e.g., money spent on substances, fees for a DUI), and standard protective behavioral strategies to limit substance-related risk. Receives: Behavioral: Standard Brief Intervention; Behavioral: Trauma-Informed and Peer-Supported Brief Intervention |
| Trauma-Informed and Peer-Supported Brief Intervention | Experimental | In addition to the components of the standard brief intervention, the TIPS-BI will include personalized feedback about participants use of substances to cope. Additionally, participants will be provided with psychoeducation about the link between substance use, trauma, and coping motives, and information highlighting the iatrogenic effects that substance use has on negative emotions. Participants will also be given a series of evidence-based alternative coping strategies for managing trauma-related distress such as anxiety, depression, and PTSD. Participants will be asked to set goals related to utilization of these alternative coping strategies. Participants will then be informed that a trained peer who is part of the research team will follow up with them via text message at the monthly time points to review adherence to their goals and offer support. Receives: Behavioral: Trauma-Informed and Peer-Supported Brief Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use
The Daily Drinking Questionnaire
Measured: Change from Baseline to 3-month follow-up
Alcohol use
The Daily Drinking Questionnaire
Measured: Change from Baseline to 6-month follow-up
Alcohol consequences
The Brief Young Adult Alcohol Consequences Questionnaire
Measured: Change from Baseline to 3-month follow-up
Alcohol consequences
The Brief Young Adult Alcohol Consequences Questionnaire
Measured: Change from Baseline to 6-month follow-up
Intervention feasibility
Percentage of drop out in the interventions
Measured: 6-month follow-up
Intervention acceptability
Participants in both the standard and modified brief interventions will be asked to rate on a Likert scale how satisfied they were with the brief intervention content.
Measured: Baseline
Peer coaching acceptability
Participants in the modified brief intervention will be asked to rate on a Likert scale how satisfied they were with the peer coaching.
Measured: Baseline
Secondary outcomes (6)
Alcohol use motives
Modified Drinking Motives Questionnaire - Revised
Measured: Baseline to 3-month follow-up
Alcohol use motives
Modified Drinking Motives Questionnaire - Revised
Measured: Baseline to 6-month follow-up
Substance-related coping
The Brief Cope Inventory; scores range from 2 to 8; higher scores reflected greater use of the specified coping method
Measured: Baseline to 3-month follow-up
Substance-related coping
The Brief Cope Inventory; scores range from 2 to 8; higher scores reflected greater use of the specified coping method
Measured: Baseline to 6-month follow-up
Coping self-efficacy
The Coping Self-Efficacy Scale; scores range from 0-260; higher scores reflect greater coping self-efficacy.
Measured: Change from baseline to 3-month follow-up
Coping self-efficacy
The Coping Self-Efficacy Scale; scores range from 0-260; higher scores reflect greater coping self-efficacy.
Measured: Change from baseline to 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Why it stopped: Accidental duplicate entry into clinicaltrials.gov
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Heavy DrinkingStudies of the same condition, open and under way.
- 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
- Model description
- Participants will be randomly assigned to either 1) a standard brief intervention 2) a modified brief intervention with peer coaching and trauma-related information
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Kentucky University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118826
- Sponsor's protocol ID
- 1839376-8
- Status last verified
- Feb 2026
- First submitted
- 5 Aug 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bonomo Y, Coffey C, Wolfe R, Lynskey M, Bowes G, Patton G. Adverse outcomes of alcohol use in adolescents. Addiction. 2001 Oct;96(10):1485-96. doi: 10.1046/j.1360-0443.2001.9610148512.x.
PubMed 11571067Wilk AI, Jensen NM, Havighurst TC. Meta-analysis of randomized control trials addressing brief interventions in heavy alcohol drinkers. J Gen Intern Med. 1997 May;12(5):274-83. doi: 10.1046/j.1525-1497.1997.012005274.x.
PubMed 9159696Kurtz SP, Pagano ME, Buttram ME, Ungar M. Brief interventions for young adults who use drugs: The moderating effects of resilience and trauma. J Subst Abuse Treat. 2019 Jun;101:18-24. doi: 10.1016/j.jsat.2019.03.009. Epub 2019 Mar 24.
PubMed 31174710Bountress KE, Cusack SE, Sheerin CM, Hawn S, Dick DM, Kendler KS, Amstadter AB. Alcohol consumption, interpersonal trauma, and drinking to cope with trauma-related distress: An auto-regressive, cross-lagged model. Psychol Addict Behav. 2019 May;33(3):221-231. doi: 10.1037/adb0000457. Epub 2019 Mar 14.
PubMed 30869917Tanner-Smith EE, Parr NJ, Schweer-Collins M, Saitz R. Effects of brief substance use interventions delivered in general medical settings: a systematic review and meta-analysis. Addiction. 2022 Apr;117(4):877-889. doi: 10.1111/add.15674. Epub 2021 Oct 14.
PubMed 34647649Teeters JB, Soltis KE, Murphy JG. A Mobile Phone-Based Brief Intervention With Personalized Feedback and Text Messaging Is Associated With Reductions in Driving After Drinking Among College Drinkers. J Stud Alcohol Drugs. 2018 Sep;79(5):710-719. doi: 10.15288/jsad.2018.79.710.
PubMed 30422784
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Refinement of a Trauma-Informed and Peer Supported Mobile Brief Intervention for Young Adult Substance Users With Interpersonal Trauma
- ClinicalTrials.gov ID
- NCT07118826
- Acronym / sponsor ID
- 1839376-8
- Conditions
- Heavy Drinking, Alcohol Drinking, Substance Use, Drinking Behavior
- Keywords
- Brief intervention, Alcohol, Trauma, Drinking, Peer coaching
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Accidental duplicate entry into clinicaltrials.gov
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Western Kentucky UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal seeks to improve a mobile-based brief intervention for young adults who engage in heavy alcohol use and have experienced interpersonal trauma. The enhancement involves incorporating adaptive coping strategies to address trauma-related distress and engaging peer coaches following the intervention to support sustained treatment effects. Participants will be randomly assigned to receive either the enhanced intervention with peer coaching or a standard version of the brief intervention. Follow-up assessments will be conducted at 3 and 6 months after the intervention. The research team expects that the trauma-informed and peer-supported brief intervention (TIPS-BI) will have low dropout rates, be well-received by participants, and lead to greater reductions in alcohol use than the standard brief intervention.
Detailed description
Alcohol is the most commonly used substance in the United States, with emerging adults (EAs) showing the highest rates of heavy use among all age groups. Persistent heavy drinking in this population is linked to a range of negative outcomes, including poor mental health, reduced life satisfaction, cognitive impairments, academic difficulties, increased risk for motor vehicle accidents, and the development of substance use disorders.
Brief interventions (BIs) for substance use typically involve one or two individual sessions that provide personalized feedback. These interventions aim to challenge inaccurate normative beliefs and emphasize personal consequences of substance use. While BIs have demonstrated success in reducing alcohol consumption and related problems in numerous clinical trials, their impact is often limited. Common challenges include small effect sizes that diminish over time and reduced effectiveness among individuals with interpersonal trauma-specifically, trauma involving human-perpetrated violence and associated emotional distress.
One explanation for these limited outcomes is that BIs are not tailored to high-risk groups such as trauma survivors. Improving BIs may require addressing two key gaps: (1) targeting coping motives-strong predictors of heavy and persistent drinking among trauma-exposed individuals that are typically not addressed in standard BIs, and (2) incorporating peer coaches to support continued gains after the intervention.
There are compelling reasons to integrate trauma content, coping strategies, and peer support into BIs for substance-using EAs. Emerging adulthood is the developmental stage with the highest risk of experiencing interpersonal trauma, which is linked to poor mental health, low social support, and elevated alcohol use. Research indicates that coping with negative emotions is a common motive for substance use in this age group-especially among trauma-exposed individuals-yet these connections are not typically addressed in standard BIs. Additionally, traditional BIs often fail to provide adaptive strategies for managing trauma-related emotional distress, despite the availability of evidence-based coping techniques.
Peer influence also plays a critical role in both initiating and maintaining substance use during emerging adulthood. Including affiliated peers in in-person BIs has improved treatment outcomes in past studies. However, few interventions have extended peer involvement to the post-intervention period, despite the demonstrated success of peer coaches in other health domains.
Further, in-person, counselor-delivered BIs have been criticized as costly and difficult to implement broadly, limiting their scalability. Since few EAs actively seek substance use prevention or treatment services, there is a pressing need for low-cost, accessible delivery methods. Given the widespread use of mobile phones, mobile-delivered BIs represent a promising approach. Early evidence suggests they can be effective with EAs, though engagement tends to be low. Incorporating peer coaches into follow-up may help address this issue and boost engagement.
The primary aim of the proposed study is to evaluate the feasibility and efficacy of a mobile-delivered, trauma-informed, and peer-supported brief intervention (TIPS-BI) for emerging adults with a history of interpersonal trauma. This study will advance the BI literature by:
- including content that links trauma to substance use and teaches emotion regulation strategies, and
- integrating trained peer coaches into the text-message follow-up phase.
A total of 190 emerging adults (ages 18-29, with 60% expected to be female) who have a history of interpersonal trauma and report recent heavy alcohol use will be enrolled in a two-arm randomized controlled trial. Participants will be assigned to one of two conditions:
Group 1: Mobile-delivered TIPS-BI with peer coach follow-up (N=95)
Group 2: Mobile-delivered standard substance use BI (N=95)
Aim 1: Assess the feasibility and acceptability of the TIPS-BI. The investigators hypothesize that the TIPS-BI will result in low dropout rates (<10%) at follow-up, comparable to the standard BI. They also expect participants to rate the TIPS-BI as satisfactory, relevant, helpful, and minimally burdensome.
Aims 2 \& 3: Evaluate the efficacy of the TIPS-BI. It is hypothesized that participants in the TIPS-BI group will show greater reductions in alcohol use and coping motives at 3- and 6-month follow-ups compared to those receiving the standard BI. Additionally, the TIPS-BI is expected to lead to greater improvements in coping self-efficacy at both follow-up time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either 1) a standard brief intervention 2) a modified brief intervention with peer coaching and trauma-related information
| Arm | Type | Receives |
|---|---|---|
| Standard Brief Intervention | Experimental | Behavioral: Standard Brief Intervention, Behavioral: Trauma-Informed and Peer-Supported Brief InterventionImmediately following completion of the baseline assessment, participants will be texted a link to a secure website which contains the participant's personalized feedback. Personalized feedback is automatically presented via a programming algorithm that is based on the participants baseline survey responses. The personalized feedback component will include a personalized substance use profile, information on peer norms, prior substance-related consequences experienced by the participant, practical costs (e.g., money spent on substances, fees for a DUI), and standard protective behavioral strategies to limit substance-related risk. |
| Trauma-Informed and Peer-Supported Brief Intervention | Experimental | Behavioral: Trauma-Informed and Peer-Supported Brief InterventionIn addition to the components of the standard brief intervention, the TIPS-BI will include personalized feedback about participants use of substances to cope. Additionally, participants will be provided with psychoeducation about the link between substance use, trauma, and coping motives, and information highlighting the iatrogenic effects that substance use has on negative emotions. Participants will also be given a series of evidence-based alternative coping strategies for managing trauma-related distress such as anxiety, depression, and PTSD. Participants will be asked to set goals related to utilization of these alternative coping strategies. Participants will then be informed that a trained peer who is part of the research team will follow up with them via text message at the monthly time points to review adherence to their goals and offer support. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 to 29
- Ability to speak and understand English
- Access to a cell phone
- Lifetime history of interpersonal trauma exposure
- Heavy alcohol use
Key exclusion criteria (1 listed)
- 1) Currently receiving psychological therapy or psychotropic medication for substance use.
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 |
|---|---|---|
| Standard Brief InterventionImmediately following completion of the baseline assessment, participants will be texted a link to a secure website which contains the participant's personalized feedback. Personalized feedback is automatically presented via a programming algorithm that is based on the participants baseline survey responses. The personalized feedback component will include a personalized substance use profile, information on peer norms, prior substance-related consequences experienced by the participant, practical costs (e.g., money spent on substances, fees for a DUI), and standard protective behavioral strategies to limit substance-related risk. | Behavioural | Standard Brief Intervention |
| Trauma-Informed and Peer-Supported Brief InterventionIn addition to the components of the standard brief intervention, the TIPS-BI will include personalized feedback about participants use of substances to cope. Additionally, participants will be provided with psychoeducation about the link between substance use, trauma, and coping motives, and information highlighting the iatrogenic effects that substance use has on negative emotions. Participants will also be given a series of evidence-based alternative coping strategies for managing trauma-related distress such as anxiety, depression, and PTSD. Participants will be asked to set goals related to utilization of these alternative coping strategies. Participants will then be informed that a trained peer who is part of the research team will follow up with them via text message at the monthly time points to review adherence to their goals and offer support. | Behavioural | Standard Brief Intervention, Trauma-Informed and Peer-Supported Brief Intervention |
Primary outcome
Alcohol use
Time frame: Change from Baseline to 3-month follow-up
The Daily Drinking Questionnaire
Alcohol use
Time frame: Change from Baseline to 6-month follow-up
The Daily Drinking Questionnaire
Alcohol consequences
Time frame: Change from Baseline to 3-month follow-up
The Brief Young Adult Alcohol Consequences Questionnaire
Alcohol consequences
Time frame: Change from Baseline to 6-month follow-up
The Brief Young Adult Alcohol Consequences Questionnaire
Intervention feasibility
Time frame: 6-month follow-up
Percentage of drop out in the interventions
Intervention acceptability
Time frame: Baseline
Participants in both the standard and modified brief interventions will be asked to rate on a Likert scale how satisfied they were with the brief intervention content.
Peer coaching acceptability
Time frame: Baseline
Participants in the modified brief intervention will be asked to rate on a Likert scale how satisfied they were with the peer coaching.
6 secondary outcomes
Alcohol use motives
Time frame: Baseline to 3-month follow-up
Alcohol use motives
Time frame: Baseline to 6-month follow-up
Substance-related coping
Time frame: Baseline to 3-month follow-up
Substance-related coping
Time frame: Baseline to 6-month follow-up
Coping self-efficacy
Time frame: Change from baseline to 3-month follow-up
Coping self-efficacy
Time frame: Change from baseline to 6-month follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 11571067Bonomo Y, Coffey C, Wolfe R, Lynskey M, Bowes G, Patton G. Adverse outcomes of alcohol use in adolescents. Addiction. 2001 Oct;96(10):1485-96. doi: 10.1046/j.1360-0443.2001.9610148512.x.
- Background: PubMed 9159696Wilk AI, Jensen NM, Havighurst TC. Meta-analysis of randomized control trials addressing brief interventions in heavy alcohol drinkers. J Gen Intern Med. 1997 May;12(5):274-83. doi: 10.1046/j.1525-1497.1997.012005274.x.
- Background: PubMed 31174710Kurtz SP, Pagano ME, Buttram ME, Ungar M. Brief interventions for young adults who use drugs: The moderating effects of resilience and trauma. J Subst Abuse Treat. 2019 Jun;101:18-24. doi: 10.1016/j.jsat.2019.03.009. Epub 2019 Mar 24.
- Background: PubMed 30869917Bountress KE, Cusack SE, Sheerin CM, Hawn S, Dick DM, Kendler KS, Amstadter AB. Alcohol consumption, interpersonal trauma, and drinking to cope with trauma-related distress: An auto-regressive, cross-lagged model. Psychol Addict Behav. 2019 May;33(3):221-231. doi: 10.1037/adb0000457. Epub 2019 Mar 14.
- Background: PubMed 34647649Tanner-Smith EE, Parr NJ, Schweer-Collins M, Saitz R. Effects of brief substance use interventions delivered in general medical settings: a systematic review and meta-analysis. Addiction. 2022 Apr;117(4):877-889. doi: 10.1111/add.15674. Epub 2021 Oct 14.
- Background: PubMed 30422784Teeters JB, Soltis KE, Murphy JG. A Mobile Phone-Based Brief Intervention With Personalized Feedback and Text Messaging Is Associated With Reductions in Driving After Drinking Among College Drinkers. J Stud Alcohol Drugs. 2018 Sep;79(5):710-719. doi: 10.15288/jsad.2018.79.710.
- Individual participant dataSharing planned: No
Related trials for Heavy Drinking
Active, not recruitingPhase 2
Gabapentin to Reduce Alcohol and Improve Viral Load Suppression
HIV, Heavy Drinking
Not yet recruitingPhase 2
N-Acetylcysteine for Bipolar and Alcohol Use Disorders
Bipolar Disorder, Alcohol Use Disorder
Not yet recruiting
Using Virtual Reality to Augment Brief Interventions for Heavy Drinking Young Adults
Alcohol Misuse
Recruiting
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
Alcohol Use Disorder, Alcoholism
Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
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 Standard Brief Intervention and Trauma-Informed and Peer-Supported Brief Intervention in people with Heavy Drinking and Alcohol Drinking, run by Western Kentucky University 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?
The sponsor lists 5 inclusion and 1 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 27 Feb 2026. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Alcohol use (time frame: Change from Baseline to 3-month follow-up). The study lists 7 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 NCT07118826, which also lists 6 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 27 Feb 2026.