AOD MisuseNCT02181283
MiSSION STRONG - Preventing AOS Misuse in the National Guard
A study testing W+W and W+P in people with AOD Misuse, run by University of Michigan at 1 site in United States.
Trial summary
National Guard members, especially those who have been combat-deployed, are at high risk for developing alcohol- and prescription-related drug problems. The use of novel Web-based interventions combined with either Web-based boosters or Peer support sessions, may have a major public health impact for the National… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AOD Misuse
- What is being tested?
- W+W and W+P
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 757 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 31 May 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals will be eligible to participate if they are in the Michigan Army National Guard and their unit is selected to participate in the proposed study. Individuals will be eligible to participate in the randomized trial if they:
- have an AUDIT-C score of 5 or more for men and 4 or more for women in the prior 4 months, indicating that they meet criteria for at-risk drinking/alcohol misuse; and/or
- use of prescribed opioids or sedatives in the prior 4 months in a manner that was inconsistent with their prescribed course of treatment (medical misuse: determined by items from an adapted PMQ).
Who cannot join
- under 18 years of age
- inability to speak and understand English
- inability to give informed, voluntary consent
- do not have access to the Web (e.g. home, work, library, WiFi-enabled tablet PCs (iPad), etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing Alcohol/Prescribed Drug Misuse in the National Guard: Web and Peer BI
National Guard members, especially those who have been combat-deployed, are at high risk for developing alcohol- and prescription-related drug problems. The use of novel Web-based interventions combined with either Web-based boosters or Peer support sessions, may have a major public health impact for the National Guard by reducing hazardous use of alcohol of prescription drugs. The aims of the study are to develop, refine and test tailored motivational Brief Interventions (BIs) with varied continuing booster reinforcements (Web vs. Peer) and to conduct a randomized controlled trial comparing the efficacy of these BIs (W+W; W+P) to usual care on subsequent alcohol/drug consumption and consequences, including injury, mental and physical-health functioning, and HIV risk behaviors at 4-, 8-, and 12-months post-enrollment.
Read the detailed description
The proposed study will test the efficacy of an easy-to-use, <40-minute, state-of-the-art tailored Web-based SBIRT (Screening, Brief Intervention, and Referral to Treatment) intervention combined with subsequent Web- or Peer-based boosters, compared to enhanced usual care (EUC). All participants will also receive a booklet with prevention information that includes general alcohol, opioid, and sedative use information as well as other health behaviors. The proposed study will screen ~ 4,300 unique Service Members as part of Soldier Readiness Processing in the Michigan National Guard (NG) to enroll 750 participants within 35 armories with alcohol and/or prescribed opioid or sedative misuse (AOS misuse). We will identify AOS misuse with a combination of the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) and an adapted version of the Pain Medication Questionnaire (PMQ). Computerized screening with touch-screen computer tablets will be used to recruit NG Service Members with AOS misuse in the prior 4 months. Participants will be randomized to one of three conditions:1) Web-delivered alcohol/prescribed drug misuse brief intervention with Web booster sessions (1/month for 3 months; W+W; n=250); 2) Web-delivered brief intervention with Peer-delivered booster sessions (at least 1/month for 3 months; W+P; n=250); or 3) Enhanced Usual Care (EUC; n=250). Random assignment will be stratified by gender and alcohol vs. prescription opioid/sedative misuse.
- Conditions
- AOD Misuse
- Being tested
- W+W, W+P
- Keywords
- alcohol, prescribed drugs, National Guard
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
W+WBehavioural
Also called Web-delivered brief intervention with Web booster sessions
Web-delivered brief intervention: Participants receive a 30-40 minute Web-based intervention which includes a tailored review of participants' goals/values, feedback regarding their present alcohol/prescribed opioid/sedative use patterns and consequences, developing a discrepancy between their alcohol or prescribed drug use, ability to meet goals and values through a decisional balance exercise, and formulation of a tailored "change plan".
Web booster sessions: Web boosters will be completed at 1, 2 and 3 months post-BI. Content is tailored to the individual based on answers to baseline questions and responses during Web-based BI. Web-based Booster will: 1) briefly ascertain current AOS use, 2) changes in AOS since completing Web BI, 3) progress toward goals, and 4) plans and encouragement for next steps.
W+PBehavioural
Also called Web-delivered brief intervention with Peer-delivered booster sessions
Web-delivered brief intervention: Participants receive a 30-40 minute Web-based intervention which includes a tailored review of participants' goals/values, feedback regarding their present alcohol/prescribed opioid/sedative use patterns and consequences, developing a discrepancy between their alcohol or prescribed drug use, ability to meet goals and values through a decisional balance exercise, and formulation of a tailored "change plan".
Peer booster sessions: The peer supporter will work with participants at 1, 2, and 3 months post-Web-based BI. Peer supports will address Service Members' own goals and will provide emotional and informational support.
| Study group | Role | What they receive |
|---|---|---|
| W+W | Active comparator | Web-delivered alcohol/prescribed drug misuse brief intervention with Web booster sessions (W+W). Receives: Behavioral: W+W |
| W+P | Active comparator | Web-delivered brief intervention with Peer-delivered booster sessions (W+P). Receives: Behavioral: W+P |
| Enhanced Usual Care | No intervention | Enhanced usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use
The full AUDIT which includes the AUDIT-C, will be used to assess alcohol use. Quantity and frequency is measured by number of drinking days, number of drinks per day and number of binge drinking days. Alcohol related consequences are measured using the modified SIP.
Measured: change over time (4-, 8- and 12-months post baseline)
Medical misuse of opioids or sedatives
Quantity and frequency is measured by number of days misused, and the NIDA-Modified ASSIST and adapted Pain Medication Questionnaire (PMQ) are used to assess medical misuse of prescribed opioids and medical misuse of prescribed sedatives. Consequences are measured using the modified SIP.
Measured: change over time (4-, 8- and 12-months post baseline)
Secondary outcomes (1)
Consequences of AOS use, including a) injury, b) mental and physical health functioning, and c) HIV-risk behaviors
3a) Injury is measured using the Revised Injury Behavior Checklist (RIBC). 3b) Mental and physical health functioning is measured using a brief version of the Short Form Health Survey (SF-12), the Generalized Anxiety Disorder (GAD-7) questionnaire, the Patient Health Questionnaire (PHQ), the Post-Traumatic Disorder Checklist-Military Version (PCL-5) and items from the Unit Risk Inventory, developed by the Army Substance Abuse Program.
3c) HIV-risk behaviors are measured using questions from the HIV Risk-Taking Behavior Scale (HRBS).
Measured: 4-, 8- and 12-months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startApr 2015
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AOD MisuseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 757 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Frederic C. Blow, University of Michigan
- Investigators
- Frederic C Blow, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181283
- Sponsor's protocol ID
- AA023122
- Other IDs
- 1R01AA023122-01
- Status last verified
- May 2018
- First submitted
- 26 Jun 2014
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blow FC, Walton M, Ilgen M, Ignacio RV, Walters H, Massey L, Barry KL, McCormick R, Coughlin LN. Peer- and web-based interventions for risky drinking among US National Guard members: Mission Strong randomized controlled trial. Addiction. 2023 Jul;118(7):1246-1257. doi: 10.1111/add.16172. Epub 2023 Apr 11.
PubMed 37041669Coughlin LN, Blow FC, Walton M, Ignacio RV, Walters H, Massey L, Barry KL, McCormick R. Predictors of Booster Engagement Following a Web-Based Brief Intervention for Alcohol Misuse Among National Guard Members: Secondary Analysis of a Randomized Controlled Trial. JMIR Ment Health. 2021 Oct 26;8(10):e29397. doi: 10.2196/29397.
PubMed 34698652
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Alcohol/Prescribed Drug Misuse in the National Guard: Web and Peer BI
- ClinicalTrials.gov ID
- NCT02181283
- Acronym / sponsor ID
- AA023122
- Conditions
- AOD Misuse
- Keywords
- alcohol, prescribed drugs, National Guard
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 757 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Apr 2015 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 3 Jul 2014 (estimated)
- 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.
National Guard members, especially those who have been combat-deployed, are at high risk for developing alcohol- and prescription-related drug problems. The use of novel Web-based interventions combined with either Web-based boosters or Peer support sessions, may have a major public health impact for the National Guard by reducing hazardous use of alcohol of prescription drugs. The aims of the study are to develop, refine and test tailored motivational Brief Interventions (BIs) with varied continuing booster reinforcements (Web vs. Peer) and to conduct a randomized controlled trial comparing the efficacy of these BIs (W+W; W+P) to usual care on subsequent alcohol/drug consumption and consequences, including injury, mental and physical-health functioning, and HIV risk behaviors at 4-, 8-, and 12-months post-enrollment.
Detailed description
The proposed study will test the efficacy of an easy-to-use, <40-minute, state-of-the-art tailored Web-based SBIRT (Screening, Brief Intervention, and Referral to Treatment) intervention combined with subsequent Web- or Peer-based boosters, compared to enhanced usual care (EUC). All participants will also receive a booklet with prevention information that includes general alcohol, opioid, and sedative use information as well as other health behaviors. The proposed study will screen ~ 4,300 unique Service Members as part of Soldier Readiness Processing in the Michigan National Guard (NG) to enroll 750 participants within 35 armories with alcohol and/or prescribed opioid or sedative misuse (AOS misuse). We will identify AOS misuse with a combination of the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) and an adapted version of the Pain Medication Questionnaire (PMQ). Computerized screening with touch-screen computer tablets will be used to recruit NG Service Members with AOS misuse in the prior 4 months. Participants will be randomized to one of three conditions:1) Web-delivered alcohol/prescribed drug misuse brief intervention with Web booster sessions (1/month for 3 months; W+W; n=250); 2) Web-delivered brief intervention with Peer-delivered booster sessions (at least 1/month for 3 months; W+P; n=250); or 3) Enhanced Usual Care (EUC; n=250). Random assignment will be stratified by gender and alcohol vs. prescription opioid/sedative misuse.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| W+W | Active comparator | Behavioral: W+WWeb-delivered alcohol/prescribed drug misuse brief intervention with Web booster sessions (W+W). |
| W+P | Active comparator | Behavioral: W+PWeb-delivered brief intervention with Peer-delivered booster sessions (W+P). |
| Enhanced Usual Care | No intervention | –Enhanced usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals will be eligible to participate if they are in the Michigan Army National Guard and their unit is selected to participate in the proposed study. Individuals will be eligible to participate in the randomized trial if they:
- have an AUDIT-C score of 5 or more for men and 4 or more for women in the prior 4 months, indicating that they meet criteria for at-risk drinking/alcohol misuse; and/or
- use of prescribed opioids or sedatives in the prior 4 months in a manner that was inconsistent with their prescribed course of treatment (medical misuse: determined by items from an adapted PMQ).
Key exclusion criteria (4 listed)
- under 18 years of age
- inability to speak and understand English
- inability to give informed, voluntary consent
- do not have access to the Web (e.g. home, work, library, WiFi-enabled tablet PCs (iPad), etc.)
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 |
|---|---|---|
| W+WAlso: Web-delivered brief intervention with Web booster sessionsWeb-delivered brief intervention: Participants receive a 30-40 minute Web-based intervention which includes a tailored review of participants' goals/values, feedback regarding their present alcohol/prescribed opioid/sedative use patterns and consequences, developing a discrepancy between their alcohol or prescribed drug use, ability to meet goals and values through a decisional balance exercise, and formulation of a tailored "change plan". Web booster sessions: Web boosters will be completed at 1, 2 and 3 months post-BI. Content is tailored to the individual based on answers to baseline questions and responses during Web-based BI. Web-based Booster will: 1) briefly ascertain current AOS use, 2) changes in AOS since completing Web BI, 3) progress toward goals, and 4) plans and encouragement for next steps. | Behavioural | W+W |
| W+PAlso: Web-delivered brief intervention with Peer-delivered booster sessionsWeb-delivered brief intervention: Participants receive a 30-40 minute Web-based intervention which includes a tailored review of participants' goals/values, feedback regarding their present alcohol/prescribed opioid/sedative use patterns and consequences, developing a discrepancy between their alcohol or prescribed drug use, ability to meet goals and values through a decisional balance exercise, and formulation of a tailored "change plan". Peer booster sessions: The peer supporter will work with participants at 1, 2, and 3 months post-Web-based BI. Peer supports will address Service Members' own goals and will provide emotional and informational support. | Behavioural | W+P |
Primary outcome
Alcohol use
Time frame: change over time (4-, 8- and 12-months post baseline)
The full AUDIT which includes the AUDIT-C, will be used to assess alcohol use. Quantity and frequency is measured by number of drinking days, number of drinks per day and number of binge drinking days. Alcohol related consequences are measured using the modified SIP.
Medical misuse of opioids or sedatives
Time frame: change over time (4-, 8- and 12-months post baseline)
Quantity and frequency is measured by number of days misused, and the NIDA-Modified ASSIST and adapted Pain Medication Questionnaire (PMQ) are used to assess medical misuse of prescribed opioids and medical misuse of prescribed sedatives. Consequences are measured using the modified SIP.
1 secondary outcome
Consequences of AOS use, including a) injury, b) mental and physical health functioning, and c) HIV-risk behaviors
Time frame: 4-, 8- and 12-months post baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- Derived from this study: PubMed 37041669Blow FC, Walton M, Ilgen M, Ignacio RV, Walters H, Massey L, Barry KL, McCormick R, Coughlin LN. Peer- and web-based interventions for risky drinking among US National Guard members: Mission Strong randomized controlled trial. Addiction. 2023 Jul;118(7):1246-1257. doi: 10.1111/add.16172. Epub 2023 Apr 11.
- Derived from this study: PubMed 34698652Coughlin LN, Blow FC, Walton M, Ignacio RV, Walters H, Massey L, Barry KL, McCormick R. Predictors of Booster Engagement Following a Web-Based Brief Intervention for Alcohol Misuse Among National Guard Members: Secondary Analysis of a Randomized Controlled Trial. JMIR Ment Health. 2021 Oct 26;8(10):e29397. doi: 10.2196/29397.
- Individual participant dataSharing planned: No
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.
Frederic C Blow, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing W+W and W+P in people with AOD Misuse, run by University of Michigan 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 1 Jun 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 over time (4-, 8- and 12-months post baseline)). The study lists 2 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 NCT02181283, 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 1 Jun 2018.