Approach Avoidance Training for Alcohol Use Disorder

Overseen By Jessica A Bomyea, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Psychotic, Bipolar, Neurodegenerative, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

176 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new computer-based treatment to help Veterans with alcohol use disorder (AUD) reduce harmful drinking. The treatment, called Approach Avoidance Training (AAT), uses a computer task to change how participants respond to alcohol-related cues. Researchers will compare participants to a group using a similar task without the alcohol focus. This trial suits Veterans who are fluent in English, have primarily been diagnosed with AUD, and have not been abstinent from alcohol for more than 90 days. As an unphased trial, it offers Veterans the opportunity to contribute to innovative research that could lead to new treatment options for AUD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires a 4-week stability if you are on psychotropic medications (drugs that affect your mood, thoughts, or behavior).

What prior data suggests that this technique is safe for Veterans with alcohol use disorder?

Research shows that Approach Avoidance Training (AAT) is generally safe for people. Studies have tested AAT in various situations, including with Veterans who have alcohol use disorder (AUD). In these studies, AAT involves a computer task where participants use a joystick to push or pull images, aiming to change automatic reactions to alcohol-related cues.

Results from these studies indicate that participants handle AAT well, with no major reports of serious side effects directly linked to the training. This suggests that AAT is a low-risk treatment option. However, as with any treatment, individual experiences may differ. It's always important to discuss any concerns with a healthcare provider before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Approach Avoidance Training (AAT) for Alcohol Use Disorder because it offers a novel way to modify automatic action tendencies. Unlike traditional treatments, like counseling or medication, which primarily focus on managing cravings or withdrawal symptoms, AAT engages participants in a computerized task using a joystick to train their brains to avoid alcohol-related cues. This method targets subconscious responses, potentially reducing alcohol consumption by altering how individuals automatically react to alcohol cues. By leveraging this unique approach, AAT could complement existing therapies and offer a fresh avenue for tackling alcohol use disorder.

What evidence suggests that Approach Avoidance Training is effective for alcohol use disorder?

Research has shown that Approach Avoidance Training (AAT), which participants in this trial may receive, can help individuals with alcohol use disorder (AUD) reduce their drinking. Studies suggest that using a computer program to alter responses to alcohol-related images can lower the risk of relapse. Specifically, previous trials have demonstrated that this training enhances outcomes when combined with regular treatment. One study found that AAT helped veterans with AUD by altering their automatic reactions to alcohol. This training reduces alcohol's appeal and encourages avoidance, leading to less drinking and greater life participation. Overall, AAT appears to be a promising tool for reducing risky drinking in individuals with AUD. ^{2 3 6 7 8}

Who Is on the Research Team?

Jessica A Bomyea, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

This trial is for English-speaking Veterans with Alcohol Use Disorder (AUD) who have been sober for no more than 90 days and are stable on any psychotropic medications for at least 4 weeks. It's not suitable for those with a history of severe mental health disorders, neurological conditions, sensory deficits, recent suicidal or homicidal thoughts, or anyone receiving concurrent psychotherapy outside standard care.

Inclusion Criteria

I have been diagnosed with alcohol use disorder and have not abstained from alcohol for more than 90 days.

Fluent in English

I have been diagnosed with alcohol use disorder and have not abstained from alcohol for more than 90 days.

Exclusion Criteria

Lifetime history of psychotic or bipolar disorder

Conditions unsafe for completing MRI scanning for those completing the scanning component only (e.g., metal in body)

Suicidal or homicidal ideation within the past month necessitating urgent higher level care

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Approach Avoidance Training (AAT) or Sham Training for 6 weeks to modify approach bias towards alcohol cues

6 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in alcohol use and functional recovery outcomes

6 months

Follow-up assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Approach Avoidance Training

Trial Overview The study tests Approach Avoidance Training (AAT), a computer-based treatment aiming to alter the impulse to seek out alcohol-related cues. This is combined with standard VA care to see if it helps reduce drinking and improve social and occupational functioning in Veterans with AUD.

How Is the Trial Designed?

Group I: Approach Avoidance Training Experimental Treatment 1 Intervention

AAT condition, participants use a joystick to respond to the color of the border surrounding the stimulus images presented (i.e., "pull for green, push for blue"). The stimuli used are alcohol-related images and neutral beverage images. To experimentally manipulate automatic action tendencies, a contingency is set between alcohol stimuli and avoidance behaviors

Group II: Sham Training Placebo Group 1 Intervention

In the Sham participants use a joystick to respond to the color of the border surrounding stimulus images presented. There is no contingency between instruction type and pictures (i.e., non-training version of the task)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Patients treated with aversion therapy for alcoholism had significantly higher abstinence rates from alcohol at both 6 and 12 months compared to those who did not receive aversion therapy, indicating its efficacy in long-term alcohol cessation.

While the aversion therapy group also showed higher abstinence rates from all mood-altering substances at 6 months, this effect was not sustained at 12 months, suggesting that the benefits of aversion therapy may diminish over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six- and twelve-month abstinence rates in inpatient alcoholics treated with either faradic aversion or chemical aversion compared with matched inpatients from a treatment registry. Smith, JW., Frawley, PJ., Polissar, NL.[2008]

A pilot study involving 1082 participants using a mobile app for alcohol avoidance training showed a significant reduction in alcohol consumption, with an average decrease of 7.8 units per week after 3 weeks and an additional reduction of 6.2 units at 3 months.

The app was well-received, with 79% of participants completing the recommended sessions and positive feedback on its user-friendly design, indicating that mobile cognitive bias modification could be a promising tool for helping individuals reduce alcohol use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol Avoidance Training as a Mobile App for Problem Drinkers: Longitudinal Feasibility Study. Laurens, MC., Pieterse, ME., Brusse-Keizer, M., et al.[2021]

This study is the first randomized controlled trial assessing the effectiveness of Approach Avoidance Training (AAT) as an adjunctive treatment for Alcohol Use Disorder (AUD) in Veterans with comorbid psychiatric conditions, involving 136 participants over 6 weeks.

If successful, AAT could provide a low-cost and effective treatment option for improving recovery outcomes in Veterans with AUD, as it specifically targets implicit biases towards alcohol-related cues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approach avoidance training versus Sham in veterans with alcohol use disorder: protocol for a randomized controlled trial. Caudle, MM., Klaming, R., Fong, C., et al.[2023]

In a study of 200 patients treated for alcoholism using a multimodal program that included aversion therapy, the abstinence rate was 71.3% during the first 12 months and 65% over an average follow-up of 20.5 months.

The current abstinence rate, defined as no alcohol use in the last 6 months, was notably high at 78.1%, indicating that aversion therapy can be an effective component of alcoholism treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term abstinence from alcohol in patients receiving aversion therapy as part of a multimodal inpatient program. Smith, JW., Frawley, PJ.[2019]

In a study of 81 individuals undergoing treatment for alcohol dependence, both approach and avoidance inclinations towards alcohol were found to significantly relate to problem recognition and treatment engagement, with avoidance inclinations linked to attending more therapy sessions.

Changes in drinking behavior were associated with changes in approach inclinations, suggesting that fostering a desire to approach positive behaviors may lead to better treatment outcomes, while avoidance inclinations were more related to initial treatment engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between approach and avoidance inclinations to use alcohol and treatment outcomes. Schlauch, RC., Stasiewicz, PR., Bradizza, CM., et al.[2021]

Detoxification is often the first step in alcoholism treatment for over 700,000 people in the U.S. daily, and it can be combined with behavioral therapies like cognitive-behavioral therapy and Alcoholics Anonymous.

A major clinical study, Project MATCH, found no significant differences in outcomes among various behavioral treatment approaches, suggesting that the choice of therapy may depend more on individual patient characteristics rather than the type of therapy itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcoholism treatment in the United States. An overview. Fuller, RK., Hiller-Sturmhöfel, S.[2023]

This study will evaluate the effectiveness of approach-avoidance training (AATP) in a virtual reality (VR) bar environment compared to traditional AATP methods, involving 204 patients with alcohol use disorder across multiple countries.

The research aims to determine if the VR-enhanced AATP leads to better outcomes in reducing drinking, craving, and impulsiveness compared to standard treatment alone, potentially making AATP more effective in real-life drinking situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a virtual reality based, approach-avoidance training program for alcohol use disorder: a study protocol. Mellentin, AI., Nielsen, AS., Ascone, L., et al.[2021]

Controlled drinking training, based on avoidance conditioning, can be an effective alternative to complete abstinence for some individuals struggling with alcohol use, as demonstrated in a case study of a 33-year-old female.

The treatment allowed the participant to engage in sexual intercourse without the need for alcohol, indicating a potential improvement in her quality of life and ability to manage drinking behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlled drinking training with a female alcoholic. Brown, RA.[2019]

The study aims to evaluate the feasibility and acceptability of 'SWIPE,' a personalized and gamified smartphone app designed to help individuals with hazardous drinking habits reduce their alcohol consumption through approach bias modification (ABM).

By recruiting 500 participants who wish to reduce their drinking, the study will assess changes in alcohol consumption and cravings over four weeks, potentially providing a convenient and accessible intervention for those who may not seek traditional treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Approach Bias Modification Smartphone App ("SWIPE") to Reduce Alcohol Use Among People Drinking at Hazardous or Harmful Levels: Protocol for an Open-Label Feasibility Study. Manning, V., Piercy, H., Garfield, JBB., et al.[2020]

A novel nicotine Approach-Avoidance-Task (AAT) training significantly modified the automatic approach bias towards nicotine-related cues in smokers, suggesting it can influence addictive behaviors.

The AAT training led to a greater reduction in nicotine consumption at a three-month follow-up compared to a sham training, indicating its potential as an effective long-term intervention for reducing smoking in psychiatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approach bias modification in inpatient psychiatric smokers. Machulska, A., Zlomuzica, A., Rinck, M., et al.[2017]

A study involving 80 participants demonstrated that both typical and novel versions of approach-avoidance training (AAT) can effectively change negative evaluations of fear-conditioned stimuli, such as a dead cat.

Despite testing a new version of AAT, there was no evidence that it was more effective than the traditional method, suggesting that both approaches can help alter fear responses, although the sample size may limit the findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does approaching puppies and avoiding a dead cat improve the effectiveness of approach-avoidance training for changing the evaluation of feared stimuli? Mertens, G., Van Dessel, P., Engelhard, IM.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37438722/

Approach avoidance training versus Sham in veterans with ... Provisional evidence supports the use of Approach Avoidance Training (AAT) - a form of computer-delivered cognitive bias modification designed ...

2. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-023-04961-z

Approach avoidance training versus Sham in veterans with ... This study is the first randomized controlled trial of AAT administered as an adjunctive treatment to standard care in Veterans with AUD and comorbid ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04054336

The Approach and Avoidance Task (AAT) in Alcoholic ... It has been shown that these trainings can enhance treatment outcome (e.g. lower relapse rates) among alcohol-addicted patients (Wiers, Eberl, Rinck, Becker, & ...

4. withpower.com withpower.com/trial/phase-alcohol-use-disorders-aud-3-2023-fdfa7

Approach Avoidance Training for Alcohol Use Disorder The proposed study will test a novel treatment for alcohol use disorders (AUD) to determine if it helps Veterans reduce their hazardous drinking and recover ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2451865425000092

Approach Bias Modification for reducing Co-Occurring ... The Approach-Avoidance Task (AAT) is a computerized program, effective in assessing implicit approach biases for both alcohol and cannabis, in which ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10337098/

Approach avoidance training versus Sham in veterans with ... The primary aim is to determine the efficacy of AAT training compared to Sham training as an adjunctive treatment in Veterans with AUD ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6299832/

Implicit Alcohol Approach and Avoidance Tendencies ... Faster alcohol approach was associated with greater overall drinking at outcome, and faster alcohol avoidance predicted fewer drinking days per week at outcome.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03338361

Study Details | NCT03338361 | Research on the Efficacy of ... The investigators evaluate the efficacy of a computerised program (T.O.P. tool) consisting of an approach avoidance training (AAT) (to retrain action tendencies ...