Alcohol Use DisorderNCT04018560
Intensive Referral to Al-Anon: Benefits to Concerned Others and Their Drinkers
A study testing Al-Anon Intensive Referral (AIR) in people with Alcohol Use Disorder, run by Palo Alto Veterans Institute for Research at 1 site in United States.
Trial summary
This study is examining the effectiveness of Al-Anon Intensive Referral (AIR) with Concerned Others (COs) of individuals in treatment for alcohol use disorders ("drinkers"). AIR's goal is to facilitate Al-Anon participation and positive outcomes among COs. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Al-Anon Intensive Referral (AIR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2017to 28 Feb 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the drinker is an adult (≥19 years old) entering a treatment episode for the primary substance of alcohol;
- the drinker signs a release for researchers to contact a CO (also an adult) he or she identifies as a family member or close friend who has had contact with the drinker on at least 12 (40%) of the past 30 days; and
- the drinker and CO can communicate in English. -
Who cannot join
- the drinker is <19 years old, not entering a treatment episode for alcohol use disorder;
- the drinker does not sign a release for researchers to contact a CO;
- the drinker and CO cannot communicate in English. -
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304
About this study
This study is examining the effectiveness of Al-Anon Intensive Referral (AIR) with Concerned Others (COs) of individuals in treatment for alcohol use disorders ("drinkers"). AIR's goal is to facilitate Al-Anon participation and positive outcomes among COs.
Read the detailed description
In a randomized controlled trial, this 4-year project is evaluating AIR's effectiveness for COs. COs and their drinkers are assessed at baseline and 3-month, 6-month, and 1-year follow-ups. Hypotheses are that, compared to usual care, AIR will increase Al-Anon participation and improve CO outcomes. We will examine hypotheses using generalized mixed-effects regression models (GLMM). This project is built on the foundation that it is essential to help COs because of their own suffering.
- Conditions
- Alcohol Use Disorder
- Being tested
- Al-Anon Intensive Referral (AIR)
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Al-Anon Intensive Referral (AIR)Behavioural
AIR is intended to facilitate Al-Anon participation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Al-Anon Intensive Referral (AIR) |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Health
Items are rated on a 5-point scale (0=never, 4=very often). Mental Health is the mean of 10 items (e.g., How often have you experienced feeling hopeful); negative symptoms (e.g., anxious) are reverse scored.
Measured: The outcome measure will be assessed up to 1 year 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 Jul 2019
- Study start7 Mar 2017
- Primary completion1 Oct 2019
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Timko, Palo Alto Veterans Institute for Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018560
- Sponsor's protocol ID
- TIM0026
- Status last verified
- May 2021
- First submitted
- 8 Jul 2019
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cucciare MA, Han X, Kennedy K, Timko C. Predictors of concerned others' Al-Anon attendance and involvement following adults' entry into treatment for an alcohol use disorder. Alcohol Clin Exp Res (Hoboken). 2025 Jul;49(7):1587-1600. doi: 10.1111/acer.70085. Epub 2025 May 26.
PubMed 40415638Timko C, Cucciare MA, Lor MC, Stein M, Vest N. Patient-Concerned Other Dyads' 12-Step Involvement and Patients' Substance Use: A Latent Class Growth Model Analysis. J Stud Alcohol Drugs. 2023 Sep;84(5):762-771. doi: 10.15288/jsad.22-00378. Epub 2023 May 18.
PubMed 37219032Timko C, Grant KM, Han X, Young LB, Cucciare MA. Al-Anon Intensive Referral to facilitate concerned others' participation in Al-Anon Family Groups: a randomized controlled trial. Addiction. 2022 Mar;117(3):590-599. doi: 10.1111/add.15670. Epub 2021 Oct 3.
PubMed 34427006
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Referral to Al-Anon: Benefits to Concerned Others and Their Drinkers
- ClinicalTrials.gov ID
- NCT04018560
- Acronym / sponsor ID
- TIM0026
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Study start
- 7 Mar 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 12 Jul 2019 (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 study is examining the effectiveness of Al-Anon Intensive Referral (AIR) with Concerned Others (COs) of individuals in treatment for alcohol use disorders ("drinkers"). AIR's goal is to facilitate Al-Anon participation and positive outcomes among COs.
Detailed description
In a randomized controlled trial, this 4-year project is evaluating AIR's effectiveness for COs. COs and their drinkers are assessed at baseline and 3-month, 6-month, and 1-year follow-ups. Hypotheses are that, compared to usual care, AIR will increase Al-Anon participation and improve CO outcomes. We will examine hypotheses using generalized mixed-effects regression models (GLMM). This project is built on the foundation that it is essential to help COs because of their own suffering.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Al-Anon Intensive Referral (AIR) |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- the drinker is an adult (≥19 years old) entering a treatment episode for the primary substance of alcohol;
- the drinker signs a release for researchers to contact a CO (also an adult) he or she identifies as a family member or close friend who has had contact with the drinker on at least 12 (40%) of the past 30 days; and
- the drinker and CO can communicate in English. -
Key exclusion criteria (3 listed)
- the drinker is <19 years old, not entering a treatment episode for alcohol use disorder;
- the drinker does not sign a release for researchers to contact a CO;
- the drinker and CO cannot communicate in English. -
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 |
|---|---|---|
| Al-Anon Intensive Referral (AIR)AIR is intended to facilitate Al-Anon participation. | Behavioural | Intervention |
Primary outcome
Mental Health
Time frame: The outcome measure will be assessed up to 1 year follow-up.
Items are rated on a 5-point scale (0=never, 4=very often). Mental Health is the mean of 10 items (e.g., How often have you experienced feeling hopeful); negative symptoms (e.g., anxious) are reverse scored.
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 5 May 2021.
- Derived from this study: PubMed 40415638Cucciare MA, Han X, Kennedy K, Timko C. Predictors of concerned others' Al-Anon attendance and involvement following adults' entry into treatment for an alcohol use disorder. Alcohol Clin Exp Res (Hoboken). 2025 Jul;49(7):1587-1600. doi: 10.1111/acer.70085. Epub 2025 May 26.
- Derived from this study: PubMed 37219032Timko C, Cucciare MA, Lor MC, Stein M, Vest N. Patient-Concerned Other Dyads' 12-Step Involvement and Patients' Substance Use: A Latent Class Growth Model Analysis. J Stud Alcohol Drugs. 2023 Sep;84(5):762-771. doi: 10.15288/jsad.22-00378. Epub 2023 May 18.
- Derived from this study: PubMed 34427006Timko C, Grant KM, Han X, Young LB, Cucciare MA. Al-Anon Intensive Referral to facilitate concerned others' participation in Al-Anon Family Groups: a randomized controlled trial. Addiction. 2022 Mar;117(3):590-599. doi: 10.1111/add.15670. Epub 2021 Oct 3.
Related trials for Alcohol Use Disorder
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
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 Al-Anon Intensive Referral (AIR) in people with Alcohol Use Disorder, run by Palo Alto Veterans Institute for Research 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 3 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 5 May 2021. 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?
Mental Health (time frame: The outcome measure will be assessed up to 1 year follow-up.). 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 NCT04018560, which also lists 3 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 5 May 2021.