Alcohol Use DisorderHaRTCNCT04267692
Harm Reduction Talking Circles for American Indians and Alaska Natives With Alcohol Use Disorders
A study testing HaRTC in people with Alcohol Use Disorder, run by Washington State University at 1 site in United States.
Trial summary
This randomized clinical trial will compare participants who receive HaRTC versus the nontreatment control arm to see if HaRTC helps urban American Indians and Alaska Natives who meet criteria for an alcohol use disorder to increase their engagement in cultural practices, enhance their quality of life, and reduce… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- HaRTC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2020to 30 Nov 2023
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being urban AI/AN,
- being at least 21 years of age (for legal reasons), and
- meeting criteria for a current AUD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
Who cannot join
- refusal or inability to consent to participation in research, and
- potential to place the safety or security of other patients or staff at risk
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Indian Health Board
Seattle, Washington, 98144
About this study
Official title: Development and Evaluation of Harm Reduction Talking Circles for Urban American Indians and Alaska Natives With Alcohol Use Disorders - Phase III Randomized Clinical Trial
This randomized clinical trial will compare participants who receive HaRTC versus the nontreatment control arm to see if HaRTC helps urban American Indians and Alaska Natives who meet criteria for an alcohol use disorder to increase their engagement in cultural practices, enhance their quality of life, and reduce their alcohol-related harm.
Read the detailed description
HaRTC refers to an alcohol treatment that integrates the traditional Native practice of Talking Circles with harm reduction, a low-barrier approach to substance-use treatment that does not require sobriety or use reduction. The HaRTC study is a collaboration between WSU, UW, and Seattle Indian Health Board (SIHB). It is funded by the National Institute on Alcohol Abuse and Alcoholism at the National Institutes of Health. In this study, researchers from WSU and UW are working together with urban-dwelling community members who have Native heritage and lived experience of alcohol use disorder as well as with traditional health professionals, staff and management at SIHB. As a team, we are tailoring, implementing, and evaluating HaRTC as a culturally appropriate treatment for urban American Indians and Alaska Natives.
This study is divided into three phases:
Phase 1: During one-on-one interviews and focus groups, WSU and UW researchers asked patients, traditional healers, staff and management at SIHB how to best tailor HaRTC.
Phase 2: The researchers assembled a community action board comprised of Native community members who have lived experience as well as traditional health professionals, staff and management at SIHB to refine the HaRTC treatment manual and procedures to best fit the needs, setting and values at SIHB based on their own lived experiences and on the findings from Phase 1. This protocol was then revisited together with our community action board and community partners to ensure appropriate physical distancing in the wake of the COVID-19 pandemic. Thus, our in-person procedures were converted to a fully virtual, online protocol.
Phase 3: Researchers are conducting a randomized clinical trial of the virtual adapted Harm Reduction Treatment Circles (HaRTC) program. Participants (N=280) in the RCT will be urban American Indians and Alaska Natives. Additionally, they must be at least 21 years of age and meet criteria for a current alcohol use disorder. Participants will provide informed consent and will be randomized (like flipping a coin) to receive either HaRTC or no-treatment control so the investigators can evaluate whether HaRTC is efficacious. Participants will be asked questions about their involvement in cultural practices, alcohol use and quality of life prior to randomization, a month into the HaRTC, after the HaRTC ends, and at 1-, 3-, and 6-month follow-up interviews. It is expected that HaRTC will help patients increase their engagement with cultural traditions, enhance their quality of life, and reduce their experience of alcohol-related harm. If so, the research team will work with SIHB to make this intervention sustainable for its community members.
- Conditions
- Alcohol Use Disorder
- Being tested
- HaRTC
- Keywords
- Indigenous Medicine, American Indian, Alaska Native, alcohol use disorder, alcohol treatment, treatment efficacy, quality of life, cultural connectedness
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaRTCOther
HaRT-C participants will attend 8, virtual, adapted, low-barrier, weekly, closed-group Talking Circles-- named Harm Reduction Treatment Circles or HaRTC -- lasting approximately 2 hours each. During the HaRTC, the circle keeper will present the day's harm reduction topic, smudge the space, and allow participants to open themselves up to the circle. Topics presented by the Circle Keeper focus on harm-reduction and improving overall quality of health. Abstinence from alcohol use is not a requirement. We will not limit participants' access to treatment or services in either arm.
| Study group | Role | What they receive |
|---|---|---|
| Harm Reduction Treatment Circles (HaRTC) | Experimental | Participants will attend 8, weekly Harm Reduction Treatment Circles. We will not limit participants' access to other treatment or services. Receives: Other: HaRTC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alcohol frequency
Alcohol and Substance Use Frequency Assessment items were adapted from the Addiction Severity Index-Fifth Edition (ASI-5th Ed) and will be used to assess frequency of alcohol use in the past 30 days. Scores range from 0 to 30 with higher scores indicating more frequent drinking.
Measured: Pre-intervention, mid-, immediate post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.
Change in Peak alcohol use
The Alcohol Quantity and Use Assessment was created by the research team for previous studies with a similar population and will be used to record the quantity of alcohol consumed on participants' heaviest, typical, and lightest drinking days in the past month. Scores are expressed in number of standard drinks with higher numbers indicating heavier drinking.
Measured: Pre-intervention, mid-, immediate post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.
Change in Alcohol-related harm
The Short Inventory of Problems-2nd Revision (SIP-2R), a psychometrically reliable and valid 15-item, Likert-scale questionnaire, measures social, occupational, and psychological problems related to alcohol use. Scores range from 0 to 45 with higher scores indicating more severe alcohol-related harm.
Measured: Pre-intervention, mid-, immediate post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.
Change in EuroQoL-5 Dimensional-5 Level
The EuroQoL-5 Dimensional-5 Level is a widely used generic measure of health status consisting of two parts. The first part (the descriptive system) assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). Each domain is rated on a 5 point likert scale. Scores range from 5-25, with higher scores indicating poorer health related quality of life.
Measured: Pre-intervention, mid-, immediately post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.
Change in Cost effectiveness
**Self-report data for cost-effectiveness analyses
-The Non-Study Resources Form: documents change in medical and nonmedical resources used by participants.
Measured: 6 months before study participation compared to 6 months after enrollment.
Change in Ethyl glucuronide
Ethyl glucuronide (EtG) urine tests will be used to validate self-reported alcohol use at each assessment. EtG, a metabolite of ethyl alcohol formed in the body after ethanol exposure, reflects alcohol consumption over the previous 72 hours. EtG (cutoff 300 mg/nl) will serve as a secondary outcome in analyses.
Measured: Pre-intervention, mid-, immediately post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start28 Sep 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Principal investigator, Lonnie Nelson, Washington State University
- Investigators
- Lonnie A Nelson, PhD, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267692
- Sponsor's protocol ID
- P60AA026112-RP2
- Other IDs
- P60AA026112
- Acronym
- HaRTC
- Status last verified
- Apr 2023
- First submitted
- 16 Dec 2019
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the data MOU signed by the 3 collaborating institutions, SIHB owns the data and grants researchers at WSU and UW the right to maintain a copy of data to use up to 6 years following study completion to fulfill study aims. Thereafter, SIHB will maintain sole ownership of and access to the data.
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Harm Reduction Talking Circles for Urban American Indians and Alaska Natives With Alcohol Use Disorders - Phase III Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04267692
- Acronym / sponsor ID
- HaRTC / P60AA026112-RP2
- Conditions
- Alcohol Use Disorder
- Keywords
- Indigenous Medicine, American Indian, Alaska Native, alcohol use disorder, alcohol treatment, treatment efficacy, quality of life, cultural connectedness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 13 Feb 2020 (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 randomized clinical trial will compare participants who receive HaRTC versus the nontreatment control arm to see if HaRTC helps urban American Indians and Alaska Natives who meet criteria for an alcohol use disorder to increase their engagement in cultural practices, enhance their quality of life, and reduce their alcohol-related harm.
Detailed description
HaRTC refers to an alcohol treatment that integrates the traditional Native practice of Talking Circles with harm reduction, a low-barrier approach to substance-use treatment that does not require sobriety or use reduction. The HaRTC study is a collaboration between WSU, UW, and Seattle Indian Health Board (SIHB). It is funded by the National Institute on Alcohol Abuse and Alcoholism at the National Institutes of Health. In this study, researchers from WSU and UW are working together with urban-dwelling community members who have Native heritage and lived experience of alcohol use disorder as well as with traditional health professionals, staff and management at SIHB. As a team, we are tailoring, implementing, and evaluating HaRTC as a culturally appropriate treatment for urban American Indians and Alaska Natives.
This study is divided into three phases:
Phase 1: During one-on-one interviews and focus groups, WSU and UW researchers asked patients, traditional healers, staff and management at SIHB how to best tailor HaRTC.
Phase 2: The researchers assembled a community action board comprised of Native community members who have lived experience as well as traditional health professionals, staff and management at SIHB to refine the HaRTC treatment manual and procedures to best fit the needs, setting and values at SIHB based on their own lived experiences and on the findings from Phase 1. This protocol was then revisited together with our community action board and community partners to ensure appropriate physical distancing in the wake of the COVID-19 pandemic. Thus, our in-person procedures were converted to a fully virtual, online protocol.
Phase 3: Researchers are conducting a randomized clinical trial of the virtual adapted Harm Reduction Treatment Circles (HaRTC) program. Participants (N=280) in the RCT will be urban American Indians and Alaska Natives. Additionally, they must be at least 21 years of age and meet criteria for a current alcohol use disorder. Participants will provide informed consent and will be randomized (like flipping a coin) to receive either HaRTC or no-treatment control so the investigators can evaluate whether HaRTC is efficacious. Participants will be asked questions about their involvement in cultural practices, alcohol use and quality of life prior to randomization, a month into the HaRTC, after the HaRTC ends, and at 1-, 3-, and 6-month follow-up interviews. It is expected that HaRTC will help patients increase their engagement with cultural traditions, enhance their quality of life, and reduce their experience of alcohol-related harm. If so, the research team will work with SIHB to make this intervention sustainable for its community members.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Harm Reduction Treatment Circles (HaRTC) | Experimental | Other: HaRTCParticipants will attend 8, weekly Harm Reduction Treatment Circles. We will not limit participants' access to other treatment or services. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- being urban AI/AN,
- being at least 21 years of age (for legal reasons), and
- meeting criteria for a current AUD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
Key exclusion criteria (2 listed)
- refusal or inability to consent to participation in research, and
- potential to place the safety or security of other patients or staff at risk
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 |
|---|---|---|
| HaRTCHaRT-C participants will attend 8, virtual, adapted, low-barrier, weekly, closed-group Talking Circles-- named Harm Reduction Treatment Circles or HaRTC -- lasting approximately 2 hours each. During the HaRTC, the circle keeper will present the day's harm reduction topic, smudge the space, and allow participants to open themselves up to the circle. Topics presented by the Circle Keeper focus on harm-reduction and improving overall quality of health. Abstinence from alcohol use is not a requirement. We will not limit participants' access to treatment or services in either arm. | Other | Harm Reduction Treatment Circles (HaRTC) |
Primary outcome
Change in Alcohol frequency
Time frame: Pre-intervention, mid-, immediate post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.
Alcohol and Substance Use Frequency Assessment items were adapted from the Addiction Severity Index-Fifth Edition (ASI-5th Ed) and will be used to assess frequency of alcohol use in the past 30 days. Scores range from 0 to 30 with higher scores indicating more frequent drinking.
Change in Peak alcohol use
Time frame: Pre-intervention, mid-, immediate post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.
The Alcohol Quantity and Use Assessment was created by the research team for previous studies with a similar population and will be used to record the quantity of alcohol consumed on participants' heaviest, typical, and lightest drinking days in the past month. Scores are expressed in number of standard drinks with higher numbers indicating heavier drinking.
Change in Alcohol-related harm
Time frame: Pre-intervention, mid-, immediate post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.
The Short Inventory of Problems-2nd Revision (SIP-2R), a psychometrically reliable and valid 15-item, Likert-scale questionnaire, measures social, occupational, and psychological problems related to alcohol use. Scores range from 0 to 45 with higher scores indicating more severe alcohol-related harm.
Change in EuroQoL-5 Dimensional-5 Level
Time frame: Pre-intervention, mid-, immediately post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.
The EuroQoL-5 Dimensional-5 Level is a widely used generic measure of health status consisting of two parts. The first part (the descriptive system) assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). Each domain is rated on a 5 point likert scale. Scores range from 5-25, with higher scores indicating poorer health related quality of life.
Change in Cost effectiveness
Time frame: 6 months before study participation compared to 6 months after enrollment.
**Self-report data for cost-effectiveness analyses -The Non-Study Resources Form: documents change in medical and nonmedical resources used by participants.
Change in Ethyl glucuronide
Time frame: Pre-intervention, mid-, immediately post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.
Ethyl glucuronide (EtG) urine tests will be used to validate self-reported alcohol use at each assessment. EtG, a metabolite of ethyl alcohol formed in the body after ethanol exposure, reflects alcohol consumption over the previous 72 hours. EtG (cutoff 300 mg/nl) will serve as a secondary outcome in analyses.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: No. According to the data MOU signed by the 3 collaborating institutions, SIHB owns the data and grants researchers at WSU and UW the right to maintain a copy of data to use up to 6 years following study completion to fulfill study aims. Thereafter, SIHB will maintain sole ownership of and access to the data.
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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.
Lonnie A Nelson, 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 HaRTC in people with Alcohol Use Disorder, 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Apr 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?
Results are not available in the source record.
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 frequency (time frame: Pre-intervention, mid-, immediate post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.). The study lists 6 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 26 Apr 2023.