Alcohol AbuseNCT02174315
Motivational Incentives for Alcohol Abstinence in American Indian and Native Alaskan Adults
A study testing Contingency Management in people with Alcohol Abuse, run by Washington State University at 1 site in United States.
Trial summary
This study examines the impact of a culturally tailored version of contingency management treatment on alcohol in 400 alcohol dependent American Indians and Alaskan Natives. Participants will be recruited from addiction treatment agencies and throughout the community. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2014to 9 Sep 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self reported American Indian/Alaskan Native
- Current alcohol dependence
- 5 or more standard drink on 1 or more occasions in the last 30 days
- Ability to read and speak English
- Ability to provide written informed consent
Who cannot join
- Illicit drug use greater than alcohol use in the last 90 days
- A risk of dangerous alcohol withdrawal
- Any medical or psychiatric condition, such as organic brain disorder, dementia, or psychotic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contingency Management Treatment of Alcohol Abuse American Indian People
This study examines the impact of a culturally tailored version of contingency management treatment on alcohol in 400 alcohol dependent American Indians and Alaskan Natives. Participants will be recruited from addiction treatment agencies and throughout the community. Those who complete a 4 week induction period will be randomized to receive 12 weeks of contingency management or a non-contingent control condition. Individuals will then be followed for an additional 3-months to assess the long term efficacy of the treatment.
- Conditions
- Alcohol Abuse
- Being tested
- Contingency Management
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Contingency Management | Experimental | Not described Receives: Behavioral: Contingency Management |
| Non-Contingent Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alcohol use as assessed by ethyl glucuronide detection in urine
Measured: Twice weekly for twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study start1 Oct 2014
- Primary completion9 Sep 2019
- Study completion9 Sep 2019
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 AbuseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael McDonell, Washington State University
- Investigators
- Michael McDonell, PhD, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174315
- Sponsor's protocol ID
- 46593-G
- Status last verified
- Apr 2023
- First submitted
- 13 May 2014
- Last updated
- 1 May 2023
- Results posted
- No
Publications
Hirchak KA, Kordas G, Lyons AJ, Herron J, Jansen K, Shaw J, McPherson SM, Roll J, Buchwald D, McDonell MG; HONOR Study Team. Investigating Secondary Alcohol Outcomes in a Contingency Management Intervention among American Indian and Alaska Native Adults. J Addict Med. 2023 May-Jun 01;17(3):e177-e182. doi: 10.1097/ADM.0000000000001116. Epub 2022 Dec 21.
PubMed 37267179Hirchak KA, Lyons AJ, Herron JL, Kordas G, Shaw JL, Jansen K, Avey JP, McPherson SM, Donovan D, Roll J, Buchwald D, Ries R, McDonell MG; HONOR Study Team. Contingency management for alcohol use disorder reduces cannabis use among American Indian and Alaska Native adults. J Subst Abuse Treat. 2022 Jun;137:108693. doi: 10.1016/j.jsat.2021.108693. Epub 2021 Dec 11.
PubMed 34952747McDonell MG, Hirchak KA, Herron J, Lyons AJ, Alcover KC, Shaw J, Kordas G, Dirks LG, Jansen K, Avey J, Lillie K, Donovan D, McPherson SM, Dillard D, Ries R, Roll J, Buchwald D; HONOR Study Team. Effect of Incentives for Alcohol Abstinence in Partnership With 3 American Indian and Alaska Native Communities: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Jun 1;78(6):599-606. doi: 10.1001/jamapsychiatry.2020.4768.
PubMed 33656561
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contingency Management Treatment of Alcohol Abuse American Indian People
- ClinicalTrials.gov ID
- NCT02174315
- Acronym / sponsor ID
- 46593-G
- Conditions
- Alcohol Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Study start
- 1 Oct 2014
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 25 Jun 2014 (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 examines the impact of a culturally tailored version of contingency management treatment on alcohol in 400 alcohol dependent American Indians and Alaskan Natives. Participants will be recruited from addiction treatment agencies and throughout the community. Those who complete a 4 week induction period will be randomized to receive 12 weeks of contingency management or a non-contingent control condition. Individuals will then be followed for an additional 3-months to assess the long term efficacy of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingency Management | Experimental | Behavioral: Contingency Management |
| Non-Contingent Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self reported American Indian/Alaskan Native
- Current alcohol dependence
- 5 or more standard drink on 1 or more occasions in the last 30 days
- Ability to read and speak English
- Ability to provide written informed consent
Key exclusion criteria (3 listed)
- Illicit drug use greater than alcohol use in the last 90 days
- A risk of dangerous alcohol withdrawal
- Any medical or psychiatric condition, such as organic brain disorder, dementia, or psychotic disorder
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 |
|---|---|---|
| Contingency Management | Behavioural | Contingency Management |
Primary outcome
Change in alcohol use as assessed by ethyl glucuronide detection in urine
Time frame: Twice weekly for twelve 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 1 May 2023.
- Derived from this study: PubMed 37267179Hirchak KA, Kordas G, Lyons AJ, Herron J, Jansen K, Shaw J, McPherson SM, Roll J, Buchwald D, McDonell MG; HONOR Study Team. Investigating Secondary Alcohol Outcomes in a Contingency Management Intervention among American Indian and Alaska Native Adults. J Addict Med. 2023 May-Jun 01;17(3):e177-e182. doi: 10.1097/ADM.0000000000001116. Epub 2022 Dec 21.
- Derived from this study: PubMed 34952747Hirchak KA, Lyons AJ, Herron JL, Kordas G, Shaw JL, Jansen K, Avey JP, McPherson SM, Donovan D, Roll J, Buchwald D, Ries R, McDonell MG; HONOR Study Team. Contingency management for alcohol use disorder reduces cannabis use among American Indian and Alaska Native adults. J Subst Abuse Treat. 2022 Jun;137:108693. doi: 10.1016/j.jsat.2021.108693. Epub 2021 Dec 11.
- Derived from this study: PubMed 33656561McDonell MG, Hirchak KA, Herron J, Lyons AJ, Alcover KC, Shaw J, Kordas G, Dirks LG, Jansen K, Avey J, Lillie K, Donovan D, McPherson SM, Dillard D, Ries R, Roll J, Buchwald D; HONOR Study Team. Effect of Incentives for Alcohol Abstinence in Partnership With 3 American Indian and Alaska Native Communities: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Jun 1;78(6):599-606. doi: 10.1001/jamapsychiatry.2020.4768.
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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.
Michael McDonell, PhD principal investigator
Washington State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management in people with Alcohol Abuse, run by Washington State University 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 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 1 May 2023. 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?
Change in alcohol use as assessed by ethyl glucuronide detection in urine (time frame: Twice weekly for twelve weeks). 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 NCT02174315, 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 1 May 2023.