Alcohol Use DisorderADP + AABMNCT03898323
Pilot Human Laboratory Study of Alcohol Approach Bias Modification (AABM) for Alcohol Use Disorder (AUD)
A study testing Alcohol Approach Bias Modification in people with Alcohol Use Disorder, run by University of California, San Francisco at 1 site in United States.
Trial summary
The overall goal of the proposed project is to improve the treatment of individuals with Alcohol Use Disorder (AUD). We will conduct a pilot feasibility trial of Approach Bias Modification (AABM) training of heavy-drinking non-treatment seeking individuals with AUD. Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Alcohol Approach Bias Modification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 31 Jan 2020
- 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 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men, ages 21-50;
- Able to read English and to complete study evaluations;
- Risky (also known as high-risk, or hazardous, or heavy) alcohol use, defined as 25-70 standard drinks per week on average over the past 30 days; Heavy (also known as risky, high-risk, or hazardous) alcohol use, defined as 15-70 standard drinks per week on average over the past 30 days.
- No more than 3 days/week of alcohol abstinence in the past 30 days, to maximize likelihood that participants will choose to drink during the laboratory sessions.
- At least 1 heavy drinking day (> 5 drinks/day) per week on average during the 30 days prior to screening.
Who cannot join
- Individuals who are seeking AUD treatment or have been in treatment within the past 6 months;
- Current DSM-V non-alcohol use disorder other than tobacco and marijuana;
- Positive urine drug test results at more than one baseline appointment for opioids, cocaine, benzodiazepines, or barbiturates;
- Regular use of psychoactive drugs including antipsychotics, anxiolytics and antidepressants during the 30 days prior to entry, as well as anticonvulsants, beta blockers, central nervous system stimulants or depressants, or other drugs that cause excessive sedation;
- Psychosis or any other serious mental illness as judged by SCID and study physician assessment;
- Medical conditions that in the judgment of the study physician contraindicate the consumption of alcohol or would make study participation hazardous;
Show all 9Show fewer
- History of serious alcohol withdrawal (e.g. seizures, DTs, hospitalization) or a Clinical Institute Withdrawal Assessment Scale (CIWA-AD) score > 8;
- Participants who report disliking beer will be excluded because beer will be provided during the alcohol self-administration periods;
- Participants who have taken any investigational drug within 4 weeks preceding study entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Health Care System
San Francisco, California, 94121
About this study
Official title: Alcohol Approach Bias Modification Effects on Alcohol Consumption: A Pilot Human Laboratory Study
The overall goal of the proposed project is to improve the treatment of individuals with Alcohol Use Disorder (AUD). We will conduct a pilot feasibility trial of Approach Bias Modification (AABM) training of heavy-drinking non-treatment seeking individuals with AUD. We will measure feasibility with respect to recruitment, retention and tolerability of AABM training and the Alcohol Drinking Paradigm (ADP). We will also assess changes in alcohol craving and alcohol consumption during ADP sessions conducted before and after 2 weeks of AABM training.
Read the detailed description
Heavy-drinking non-treatment seeking male community volunteers with a diagnosis of AUD will receive 2 weeks of AABM training preceded and followed by a 1-day ADP session.
AABM training is a computer training program that participants interact with by pushing and pulling a joystick. Participants are asked to respond to the format of a presented picture, irrespective of the pictures' content. Training effect is achieved by presenting alcohol pictures in push format only and non-alcoholic drinks in pull format only. Training is conducted in 3 sessions per week for 2 weeks, for a total of 6 sessions.
The ADP session is a one day human laboratory session taking place at the SFVA Medical Center. This human laboratory session involves the self-administration of alcoholic beverages by research participants under highly structured, observed conditions in order to evaluate the effects of the study intervention (AABM training) on alcohol craving and alcohol consumption.
The investigators hoped to recruit 12 participants to enroll and start the clinical trial over the course of 1 year.
- Conditions
- Alcohol Use Disorder
- Being tested
- Alcohol Approach Bias Modification
- Keywords
- human laboratory, alcohol approach bias modification, alcohol use disorder, non-treatment seeking
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol Approach Bias ModificationDevice
Computerized training
| Study group | Role | What they receive |
|---|---|---|
| AABM Training | Experimental | Alcohol Approach Bias Modification (AABM) training is a computer training program that participants interact with by pushing and pulling a joystick. Participants are asked to respond to the format of a presented picture, irrespective of the pictures' content. Training effect is achieved by presenting alcohol pictures in push format only and non-alcoholic drinks in pull format only. AABM training consists of 3 sessions per week over 2 weeks, for a total of 6 sessions. Receives: Device: Alcohol Approach Bias Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility
The number of participants who enrolled and actually started study treatment over the 12-month recruitment period.
Measured: 12 months
Retention Feasibility
Retention feasibility as measured by the percentage of participants completing Alcohol Drinking Paradigm (ADP) sessions 1 and 2 and completing the 2-week course of 6 AABM training sessions.
Measured: 6 weeks
Tolerability Feasibility
Tolerability feasibility is measured by the number and percent of participants experiencing each adverse event.
Measured: 6 weeks
Secondary outcomes (2)
Alcohol Craving
Alcohol craving will be measured during ADP sessions 1 and 2 using the Alcohol Urge Questionnaire (AUQ).
Alcohol craving will be measured during Alcohol Drinking Paradigm (ADP) sessions 1 and 2, using the total score of the Alcohol Urge Questionnaire (AUQ). The AUQ has 8 items. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7; items 2 and 7 are reverse scored). Higher scores reflect greater craving. Total score range is from a minimum of 8 to a maximum of 56. The AUQ is administered before alcohol administration and at various times after alcohol administration. The AUQ score reported here is the highest AUQ score obtained for that ADP session.
Measured: 6 weeks
Alcohol Consumption (Number of Standard Drinks Consumed)
Alcohol consumption will be measured during ADP sessions 1 and 2 using the number of alcoholic standard drinks consumed during ADP session 1 (before 2 weeks of AABM training) and ADP session 2 (after the 2 weeks of AABM training). Consumption was measured using the number of alcoholic standard drinks consumed during the ADP sessions. A standard drink per NIAAA definition is 14 grams of pure alcohol.
Measured: 2 days (1 day each for ADP session 1 and 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start1 Feb 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco VA Health Care System
- Responsible party
- Sponsor
- Investigators
- Steven L. Batki, MD, Principal investigator, University of California, San Francisco/San Francisco VA Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898323
- Sponsor's protocol ID
- UCSF REAC RAP
- Acronym
- ADP + AABM
- Status last verified
- May 2024
- First submitted
- 2 Jan 2019
- Last updated
- 18 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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 Effects on Alcohol Consumption: A Pilot Human Laboratory Study
- ClinicalTrials.gov ID
- NCT03898323
- Acronym / sponsor ID
- ADP + AABM / UCSF REAC RAP
- Conditions
- Alcohol Use Disorder
- Keywords
- human laboratory, alcohol approach bias modification, alcohol use disorder, non-treatment seeking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- San Francisco VA Health Care System
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Posted 18 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of the proposed project is to improve the treatment of individuals with Alcohol Use Disorder (AUD). We will conduct a pilot feasibility trial of Approach Bias Modification (AABM) training of heavy-drinking non-treatment seeking individuals with AUD. We will measure feasibility with respect to recruitment, retention and tolerability of AABM training and the Alcohol Drinking Paradigm (ADP). We will also assess changes in alcohol craving and alcohol consumption during ADP sessions conducted before and after 2 weeks of AABM training.
Detailed description
Heavy-drinking non-treatment seeking male community volunteers with a diagnosis of AUD will receive 2 weeks of AABM training preceded and followed by a 1-day ADP session.
AABM training is a computer training program that participants interact with by pushing and pulling a joystick. Participants are asked to respond to the format of a presented picture, irrespective of the pictures' content. Training effect is achieved by presenting alcohol pictures in push format only and non-alcoholic drinks in pull format only. Training is conducted in 3 sessions per week for 2 weeks, for a total of 6 sessions.
The ADP session is a one day human laboratory session taking place at the SFVA Medical Center. This human laboratory session involves the self-administration of alcoholic beverages by research participants under highly structured, observed conditions in order to evaluate the effects of the study intervention (AABM training) on alcohol craving and alcohol consumption.
The investigators hoped to recruit 12 participants to enroll and start the clinical trial over the course of 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AABM Training | Experimental | Device: Alcohol Approach Bias ModificationAlcohol Approach Bias Modification (AABM) training is a computer training program that participants interact with by pushing and pulling a joystick. Participants are asked to respond to the format of a presented picture, irrespective of the pictures' content. Training effect is achieved by presenting alcohol pictures in push format only and non-alcoholic drinks in pull format only. AABM training consists of 3 sessions per week over 2 weeks, for a total of 6 sessions. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men, ages 21-50;
- Able to read English and to complete study evaluations;
- Risky (also known as high-risk, or hazardous, or heavy) alcohol use, defined as 25-70 standard drinks per week on average over the past 30 days; Heavy (also known as risky, high-risk, or hazardous) alcohol use, defined as 15-70 standard drinks per week on average over the past 30 days.
- No more than 3 days/week of alcohol abstinence in the past 30 days, to maximize likelihood that participants will choose to drink during the laboratory sessions.
- At least 1 heavy drinking day (> 5 drinks/day) per week on average during the 30 days prior to screening.
Key exclusion criteria (9 listed)
- Individuals who are seeking AUD treatment or have been in treatment within the past 6 months;
- Current DSM-V non-alcohol use disorder other than tobacco and marijuana;
- Positive urine drug test results at more than one baseline appointment for opioids, cocaine, benzodiazepines, or barbiturates;
- Regular use of psychoactive drugs including antipsychotics, anxiolytics and antidepressants during the 30 days prior to entry, as well as anticonvulsants, beta blockers, central nervous system stimulants or depressants, or other drugs that cause excessive sedation;
- Psychosis or any other serious mental illness as judged by SCID and study physician assessment;
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 |
|---|---|---|
| Alcohol Approach Bias ModificationComputerized training | Device | AABM Training |
Primary outcome
Recruitment Feasibility
Time frame: 12 months
The number of participants who enrolled and actually started study treatment over the 12-month recruitment period.
Retention Feasibility
Time frame: 6 weeks
Retention feasibility as measured by the percentage of participants completing Alcohol Drinking Paradigm (ADP) sessions 1 and 2 and completing the 2-week course of 6 AABM training sessions.
Tolerability Feasibility
Time frame: 6 weeks
Tolerability feasibility is measured by the number and percent of participants experiencing each adverse event.
2 secondary outcomes
Alcohol Craving
Time frame: 6 weeks
Alcohol Consumption (Number of Standard Drinks Consumed)
Time frame: 2 days (1 day each for ADP session 1 and 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- 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.
Steven L. Batki, MD principal investigator
University of California, San Francisco/San Francisco VA Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol Approach Bias Modification 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 5 inclusion and 9 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. 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 18 Jun 2024). 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?
Recruitment Feasibility (time frame: 12 months). The study lists 3 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 18 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.