Alcohol DependencePhase 3MAAEZNCT01382316
Making Alcoholics Anonymous Easier
A Phase 3 study testing Making Alcoholics Anonymous Easier (MAAEZ) in people with Alcohol Dependence and Drug Dependence, run by Alcohol Research Group at 1 site in United States.
Trial summary
This study tests the effectiveness of Making Alcoholics Anonymous Easier (MAAEZ), a manual-guided intervention designed to help alcohol and drug dependent clients connect with individuals encountered in AA. An OFF/ON design was used (n=508). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Dependence, Drug Dependence
- What is being tested?
- Making Alcoholics Anonymous Easier (MAAEZ)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Aug 2007
- Phase
- Phase 3
- 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
- current alcohol or drug dependence diagnosis
Who cannot join
- incapacitating mental or physical health; under age 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Alcohol Research Group
Emeryville, California, 94608
About this study
Official title: Making Alcoholics Anonymous Easier: A Group TSF Approach
This study tests the effectiveness of Making Alcoholics Anonymous Easier (MAAEZ), a manual-guided intervention designed to help alcohol and drug dependent clients connect with individuals encountered in AA. An OFF/ON design was used (n=508). MAAEZ effectiveness was determined by comparing abstinence rates of participants recruited during ON (MAAEZ intervention) and OFF (usual care) conditions and by studying the effect of the number of MAAEZ sessions attended. Better outcomes were hypothesized for MAAEZ vs. usual care. At 12 months, more clients in the ON condition (vs. OFF) reported past 30-day abstinence from alcohol, drugs, and both alcohol and drugs. Abstinence increased for each additional MAAEZ session received. MAAEZ appeared especially effective for those with more prior AA exposure, severe psychiatric problems, and atheists/agnostics. Mechanisms of action for MAAEZ (mediators of the MAAEZ effect) include: doing service in AA/NA/CA; having a sponsor; having a social network supportive of abstinence; and comfort being in meetings. MAAEZ represents an evidence-based intervention that is easily implemented in existing treatment programs.
- Conditions
- Alcohol Dependence, Drug Dependence
- Being tested
- Making Alcoholics Anonymous Easier (MAAEZ), Usual care
- Keywords
- 12-step facilitation, Alcoholics Anonymous, Narcotics Anonymous, AA, Self-help
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Making Alcoholics Anonymous Easier (MAAEZ)Behavioural
Also called MAAEZ
6-week, 90-minute, manualized, 12-step facilitation intervention consisting of 6 weekly session. First session is introduction. Four following core sessions attended in any order: sponsorship, principles not personalities, spirituality, living Sober. Last session, return to intro session as graduate.
Usual careBehavioural
Group format, six weekly education sessions about alcohol and drugs
| Study group | Role | What they receive |
|---|---|---|
| Making Alcoholics Anonymous Easier | Experimental | Six session, group format intervention, consisting of introductory session, four core sessions (sponsorship, principles not personalities, spirituality, living sober), and return to introductory session as MAAEZ graduate Receives: Behavioral: Making Alcoholics Anonymous Easier (MAAEZ) |
| Usual care | Active comparator | Usual group sessions on education about alcohol and drug problems Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol and drug abstinence
No alcohol and no drug consumed during the 30 days prior to 12-month follow-up interview
Measured: Past 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJul 2005
- Primary completionMay 2006
- Study completionAug 2007
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 DependenceStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcohol Research Group
- Sponsor type
- University, hospital or other
- Investigators
- Lee A Kaskutas, Dr.P.H., Principal investigator, Alcohol Research Group, Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382316
- Sponsor's protocol ID
- R01AA014688
- Acronym
- MAAEZ
- Status last verified
- Jun 2011
- First submitted
- 24 Jun 2011
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kaskutas LA, Subbaraman MS, Witbrodt J, Zemore SE. Effectiveness of Making Alcoholics Anonymous Easier: a group format 12-step facilitation approach. J Subst Abuse Treat. 2009 Oct;37(3):228-39. doi: 10.1016/j.jsat.2009.01.004. Epub 2009 Apr 1.
PubMed 19339148Subbaraman MS, Kaskutas LA, Zemore S. Sponsorship and service as mediators of the effects of Making Alcoholics Anonymous Easier (MAAEZ), a 12-step facilitation intervention. Drug Alcohol Depend. 2011 Jul 1;116(1-3):117-24. doi: 10.1016/j.drugalcdep.2010.12.008. Epub 2011 Feb 2.
PubMed 21288660Zemore SE, Kaskutas LA. Development and validation of the Alcoholics Anonymous Intention Measure (AAIM). Drug Alcohol Depend. 2009 Oct 1;104(3):204-11. doi: 10.1016/j.drugalcdep.2009.04.019. Epub 2009 Jul 5.
PubMed 19581057
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Making Alcoholics Anonymous Easier: A Group TSF Approach
- ClinicalTrials.gov ID
- NCT01382316
- Acronym / sponsor ID
- MAAEZ / R01AA014688
- Conditions
- Alcohol Dependence, Drug Dependence
- Keywords
- 12-step facilitation, Alcoholics Anonymous, Narcotics Anonymous, AA, Self-help
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- Alcohol Research GroupUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- May 2006 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 27 Jun 2011 (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.
This study tests the effectiveness of Making Alcoholics Anonymous Easier (MAAEZ), a manual-guided intervention designed to help alcohol and drug dependent clients connect with individuals encountered in AA. An OFF/ON design was used (n=508). MAAEZ effectiveness was determined by comparing abstinence rates of participants recruited during ON (MAAEZ intervention) and OFF (usual care) conditions and by studying the effect of the number of MAAEZ sessions attended. Better outcomes were hypothesized for MAAEZ vs. usual care. At 12 months, more clients in the ON condition (vs. OFF) reported past 30-day abstinence from alcohol, drugs, and both alcohol and drugs. Abstinence increased for each additional MAAEZ session received. MAAEZ appeared especially effective for those with more prior AA exposure, severe psychiatric problems, and atheists/agnostics. Mechanisms of action for MAAEZ (mediators of the MAAEZ effect) include: doing service in AA/NA/CA; having a sponsor; having a social network supportive of abstinence; and comfort being in meetings. MAAEZ represents an evidence-based intervention that is easily implemented in existing treatment programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Making Alcoholics Anonymous Easier | Experimental | Behavioral: Making Alcoholics Anonymous Easier (MAAEZ)Six session, group format intervention, consisting of introductory session, four core sessions (sponsorship, principles not personalities, spirituality, living sober), and return to introductory session as MAAEZ graduate |
| Usual care | Active comparator | Behavioral: Usual careUsual group sessions on education about alcohol and drug problems |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- current alcohol or drug dependence diagnosis
Key exclusion criteria (1 listed)
- incapacitating mental or physical health; under age 18
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 |
|---|---|---|
| Making Alcoholics Anonymous Easier (MAAEZ)Also: MAAEZ6-week, 90-minute, manualized, 12-step facilitation intervention consisting of 6 weekly session. First session is introduction. Four following core sessions attended in any order: sponsorship, principles not personalities, spirituality, living Sober. Last session, return to intro session as graduate. | Behavioural | Making Alcoholics Anonymous Easier |
| Usual careGroup format, six weekly education sessions about alcohol and drugs | Behavioural | Usual care |
Primary outcome
Alcohol and drug abstinence
Time frame: Past 30 days
No alcohol and no drug consumed during the 30 days prior to 12-month follow-up interview
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 27 Jun 2011.
- Background: PubMed 19339148Kaskutas LA, Subbaraman MS, Witbrodt J, Zemore SE. Effectiveness of Making Alcoholics Anonymous Easier: a group format 12-step facilitation approach. J Subst Abuse Treat. 2009 Oct;37(3):228-39. doi: 10.1016/j.jsat.2009.01.004. Epub 2009 Apr 1.
- Background: PubMed 21288660Subbaraman MS, Kaskutas LA, Zemore S. Sponsorship and service as mediators of the effects of Making Alcoholics Anonymous Easier (MAAEZ), a 12-step facilitation intervention. Drug Alcohol Depend. 2011 Jul 1;116(1-3):117-24. doi: 10.1016/j.drugalcdep.2010.12.008. Epub 2011 Feb 2.
- Background: PubMed 19581057Zemore SE, Kaskutas LA. Development and validation of the Alcoholics Anonymous Intention Measure (AAIM). Drug Alcohol Depend. 2009 Oct 1;104(3):204-11. doi: 10.1016/j.drugalcdep.2009.04.019. Epub 2009 Jul 5.
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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.
Lee A Kaskutas, Dr.P.H. principal investigator
Alcohol Research Group, Public Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Making Alcoholics Anonymous Easier (MAAEZ) in people with Alcohol Dependence and Drug Dependence, run by Alcohol Research Group 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 1 inclusion and 1 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 27 Jun 2011. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 and drug abstinence (time frame: Past 30 days). 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 NCT01382316, 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 27 Jun 2011; AzTrials last refreshed its copy on 29 Oct 2026.