Alcohol Use DisorderAABMNCT02600832
AABM to Decrease Problem Drinking and Impulsivity in Veterans With AUD: A Pilot Study
A study testing AABM Training in people with Alcohol Use Disorder, run by University of California, San Francisco at 1 site in United States.
Trial summary
The proposed study is a pilot prospective, parallel groups, randomized, double blind, sham training-controlled, 9-session (over 3 weeks) clinical trial of AABM in 32 male and female veterans entering treatment for AUD at the VA Medical Center at San Francisco, California, between ages 18-65. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- AABM Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 7 Feb 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female veterans eligible for VA services.
- Ages 18-65
- Must meet criteria for current (not in remission) AUD using the Diagnostic Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- Must report "at-risk" or "heavy" drinking by NIH/NIAAA (National Institute on Health/National Institute on Alcohol Abuse and Alcoholism) criteria (>3 drinks/day or >7/week for women; >4 drinks/day or >14/week for men) for at least one week in the last 90 days.
- Must express a desire to reduce, stop or abstain from alcohol use.
- Must be enrolled in AUD treatment at the San Francisco Veterans Affairs Health Care System.
Who cannot join
- Psychotic disorders, bipolar disorder, dementia, or other psychiatric or medical condition judged to be unstable.
- Concurrent participation in another AUD treatment study.
- Needing acute medical detoxification from alcohol based on a score ≥ 12 on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD).
- Subjects legally mandated to participate in an alcohol treatment program.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center San Francisco
San Francisco, California, 94121
About this study
Official title: Alcohol Approach Bias Modification to Decrease Problem Drinking and Impulsivity in Veterans With AUD: A Pilot Study
The proposed study is a pilot prospective, parallel groups, randomized, double blind, sham training-controlled, 9-session (over 3 weeks) clinical trial of AABM in 32 male and female veterans entering treatment for AUD at the VA Medical Center at San Francisco, California, between ages 18-65. The study consists of screening, 3-week AABM training, Week-4 post-test, and Week-12 follow-up. Assessment of inhibitory control, alcohol approach bias and craving will be administered at baseline and Week-4. Immediately following screening, patients will be randomly assigned to receive 9 sessions of real or sham AABM training (16 subjects each) taking place over three weeks. Following the 3 weeks of training, patients will complete a Week-4 post-test which includes assessment of alcohol approach bias, inhibitory control, and craving and a Week-12 follow-up assessing drinking behavior.
Read the detailed description
The overall goal of the proposed project is to improve the treatment of veterans who consume alcohol at hazardous or harmful levels. We will conduct a pilot controlled clinical trial to assess the feasibility and acceptability of implementing an Alcohol Approach Bias Modification (AABM) task in veterans seeking outpatient treatment for alcohol use disorder (AUD). The investigators will also explore the efficacy of AABM to reduce alcohol use and enhance executive function. The proposed study is designed to test AABM as a novel, acceptable, safe, low-cost intervention to augment and boost the efficacy of standard outpatient treatment for reducing alcohol use and simultaneously improving executive function in veterans with AUD.
The proposed project will pursue three primary aims in veterans with an AUD who are drinking alcohol at hazardous or harmful levels: 1) Establish the feasibility of enrolling and retaining veterans with AUD for a 3-week randomized trial of AABM; 2) Obtain preliminary assessment of the efficacy of AABM treatment to decrease alcohol approach bias and alcohol use; 3) Obtain preliminary assessment of the efficacy of AABM treatment to improve neurocognitive functioning domains that typically show deficits in AUD populations. To achieve these aims, we will conduct pilot prospective, parallel groups, randomized, double blind, sham training-controlled, 9-session (over 3 weeks) clinical trial of AABM in 32 male and female veterans entering treatment for AUD at the San Francisco VA Medical Center. We expect that this study will provide empirical data for recruitment, attrition and effect size estimation for a future randomized trial to definitively test that AABM reduces alcohol use and improves executive function in veterans with AUD. Moreover, findings from the proposed project are expected to improve the care of veterans with AUD, and by extension, to aid families and communities affected by the sequelae of these problems.
- Conditions
- Alcohol Use Disorder
- Being tested
- AABM Training, Sham Training
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AABM TrainingBehavioural
Also called AABM
The investigators will use a training version of the Alcohol Approach-Avoidance Task (AAT), in which patients are asked to respond to the format of presented pictures, irrespective of the pictures' content. Pushing a presented picture away will decrease picture size, whereas pulling a picture closer will increase size. There are 2 categories of pictures; 20 different alcoholic and 20 different non-alcoholic beverages. Training effect is achieved by presenting alcohol pictures in push format only and non-alcoholic drinks in pull format only. Two hundred training trials are presented per session.
Sham TrainingBehavioural
Sham training is identical to AABM training, except pictures are presented randomly in both formats.
| Study group | Role | What they receive |
|---|---|---|
| AABM Training | Experimental | Immediately following screening, patients will be randomly assigned to receive 9 sessions of real AABM training (16 subjects each) taking place over three weeks. Receives: Behavioral: AABM Training |
| Sham Training | Sham comparator | Immediately following screening, patients will be randomly assigned to receive 9 sessions of sham training (16 subjects each) taking place over three weeks. Receives: Behavioral: Sham Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
retainment
Number of participants completing the 9 sessions of AABM or sham training divided by the total number of participants randomized to start AABM or sham training.
Measured: 4 weeks
Secondary outcomes (2)
Drinks per week (DPW)
Number of standard alcohol drinks per week.
Measured: 4 weeks
Heavy Drinking Days Per Week (HDD)
Total number of heavy drinking days per week as defined by NIAAA criteria (>3 drinks/day for women; >4 drinks/day for men).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startJan 2016
- Primary completion7 Feb 2018
- Study completion7 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600832
- Sponsor's protocol ID
- 24034
- Acronym
- AABM
- Status last verified
- Dec 2018
- First submitted
- 5 Nov 2015
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Approach Bias Modification to Decrease Problem Drinking and Impulsivity in Veterans With AUD: A Pilot Study
- ClinicalTrials.gov ID
- NCT02600832
- Acronym / sponsor ID
- AABM / 24034
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Study start
- Jan 2016
- Primary completion
- 7 Feb 2018 (actual)
- Study completion
- 7 Feb 2018 (actual)
- First posted
- 9 Nov 2015 (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.
The proposed study is a pilot prospective, parallel groups, randomized, double blind, sham training-controlled, 9-session (over 3 weeks) clinical trial of AABM in 32 male and female veterans entering treatment for AUD at the VA Medical Center at San Francisco, California, between ages 18-65. The study consists of screening, 3-week AABM training, Week-4 post-test, and Week-12 follow-up. Assessment of inhibitory control, alcohol approach bias and craving will be administered at baseline and Week-4. Immediately following screening, patients will be randomly assigned to receive 9 sessions of real or sham AABM training (16 subjects each) taking place over three weeks. Following the 3 weeks of training, patients will complete a Week-4 post-test which includes assessment of alcohol approach bias, inhibitory control, and craving and a Week-12 follow-up assessing drinking behavior.
Detailed description
The overall goal of the proposed project is to improve the treatment of veterans who consume alcohol at hazardous or harmful levels. We will conduct a pilot controlled clinical trial to assess the feasibility and acceptability of implementing an Alcohol Approach Bias Modification (AABM) task in veterans seeking outpatient treatment for alcohol use disorder (AUD). The investigators will also explore the efficacy of AABM to reduce alcohol use and enhance executive function. The proposed study is designed to test AABM as a novel, acceptable, safe, low-cost intervention to augment and boost the efficacy of standard outpatient treatment for reducing alcohol use and simultaneously improving executive function in veterans with AUD.
The proposed project will pursue three primary aims in veterans with an AUD who are drinking alcohol at hazardous or harmful levels: 1) Establish the feasibility of enrolling and retaining veterans with AUD for a 3-week randomized trial of AABM; 2) Obtain preliminary assessment of the efficacy of AABM treatment to decrease alcohol approach bias and alcohol use; 3) Obtain preliminary assessment of the efficacy of AABM treatment to improve neurocognitive functioning domains that typically show deficits in AUD populations. To achieve these aims, we will conduct pilot prospective, parallel groups, randomized, double blind, sham training-controlled, 9-session (over 3 weeks) clinical trial of AABM in 32 male and female veterans entering treatment for AUD at the San Francisco VA Medical Center. We expect that this study will provide empirical data for recruitment, attrition and effect size estimation for a future randomized trial to definitively test that AABM reduces alcohol use and improves executive function in veterans with AUD. Moreover, findings from the proposed project are expected to improve the care of veterans with AUD, and by extension, to aid families and communities affected by the sequelae of these problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AABM Training | Experimental | Behavioral: AABM TrainingImmediately following screening, patients will be randomly assigned to receive 9 sessions of real AABM training (16 subjects each) taking place over three weeks. |
| Sham Training | Sham comparator | Behavioral: Sham TrainingImmediately following screening, patients will be randomly assigned to receive 9 sessions of sham training (16 subjects each) taking place over three weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female veterans eligible for VA services.
- Ages 18-65
- Must meet criteria for current (not in remission) AUD using the Diagnostic Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- Must report "at-risk" or "heavy" drinking by NIH/NIAAA (National Institute on Health/National Institute on Alcohol Abuse and Alcoholism) criteria (>3 drinks/day or >7/week for women; >4 drinks/day or >14/week for men) for at least one week in the last 90 days.
- Must express a desire to reduce, stop or abstain from alcohol use.
Key exclusion criteria (4 listed)
- Psychotic disorders, bipolar disorder, dementia, or other psychiatric or medical condition judged to be unstable.
- Concurrent participation in another AUD treatment study.
- Needing acute medical detoxification from alcohol based on a score ≥ 12 on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD).
- Subjects legally mandated to participate in an alcohol treatment program.
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 |
|---|---|---|
| AABM TrainingAlso: AABMThe investigators will use a training version of the Alcohol Approach-Avoidance Task (AAT), in which patients are asked to respond to the format of presented pictures, irrespective of the pictures' content. Pushing a presented picture away will decrease picture size, whereas pulling a picture closer will increase size. There are 2 categories of pictures; 20 different alcoholic and 20 different non-alcoholic beverages. Training effect is achieved by presenting alcohol pictures in push format only and non-alcoholic drinks in pull format only. Two hundred training trials are presented per session. | Behavioural | AABM Training |
| Sham TrainingSham training is identical to AABM training, except pictures are presented randomly in both formats. | Behavioural | Sham Training |
Primary outcome
retainment
Time frame: 4 weeks
Number of participants completing the 9 sessions of AABM or sham training divided by the total number of participants randomized to start AABM or sham training.
2 secondary outcomes
Drinks per week (DPW)
Time frame: 4 weeks
Heavy Drinking Days Per Week (HDD)
Time frame: 4 weeks
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 18 Jun 2024.
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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 AABM Training in people with Alcohol Use Disorder, run by University of California, San Francisco 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 6 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 18 Jun 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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?
retainment (time frame: 4 weeks). 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 18 Jun 2024.