Smoking Cessation for American Indian Women

Overseen By Patricia Nez Henderson, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Black Hills Center for American Indian Health

Disqualifiers: Cognitive impairment, Pregnancy, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to help American Indian women quit smoking, particularly those who have experienced intimate partner violence (IPV). It employs a culturally-sensitive and trauma-informed approach, emphasizing Lakota values, mindfulness, and storytelling. The trial also examines the program's impact on alcohol and drug use. Women who smoke at least five cigarettes a day, live in the Rapid City, SD area, and have recently experienced IPV may be suitable candidates.

As an unphased trial, this study provides a unique opportunity to contribute to culturally-tailored health solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this intervention is safe for participants?

Research shows that the "Healing Within" program aims to help American Indian women who have experienced intimate partner violence quit smoking. The study focuses on improving and testing the program, with an emphasis on understanding its safety.

Detailed safety information from past studies on this specific program is not available. However, because it is culturally tailored and trauma-informed, it likely employs methods like mindfulness and storytelling, which are generally safe and well-tolerated. These methods aim to help participants quit smoking while respecting their cultural and personal experiences.

The trial is in the "Not Applicable" phase, meaning it is being tested for effectiveness and acceptability rather than specific safety outcomes. While there is no direct evidence of harm, the program is still under study to ensure it is suitable and effective for the target group.

Prospective participants should discuss any concerns with the study coordinators or their healthcare provider. They can provide more specific information tailored to individual needs and situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

"Healing Within" is unique because it offers a culturally-tailored, trauma-informed approach specifically designed for American Indian women experiencing intimate partner violence. Unlike standard smoking cessation treatments, which often involve nicotine replacement therapy or medications like varenicline, this intervention leverages Lakota values, mindfulness techniques, and storytelling. Researchers are excited because it not only addresses the physical aspect of quitting smoking but also supports mental and emotional healing, making it a holistic option that resonates with the participants' cultural and personal experiences.

What evidence suggests that the Healing Within intervention is effective for smoking cessation in American Indian women experiencing intimate partner violence?

Research has shown that the "Healing Within" program, which participants in this trial will receive, may help American Indian women quit smoking. In a previous study focused on the California American Indian/Alaska Native community, 5.7% of women in the program quit smoking after 18 months, compared to a 3.1% quit rate in a group that did not participate. The program incorporates cultural values and mindfulness, which can be especially beneficial for women who have experienced intimate partner violence. These elements are believed to improve mental health and resilience, making it easier to quit smoking. Overall, the program aims to provide culturally and emotionally supportive methods to help people stop smoking. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for American Indian women from the Northern Plains who smoke at least five cigarettes daily, have faced intimate partner violence recently, live around Rapid City, SD, are willing to quit smoking during the study and are 18 or older.

Inclusion Criteria

I live in or near Rapid City, SD.

I am an American Indian woman from the Northern Plains.

I smoke at least five cigarettes daily.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an 8-week culturally-tailored, trauma-informed smoking cessation intervention

8 weeks

Weekly sessions

Follow-up

Participants are monitored for smoking cessation success and changes in alcohol and drug use

3 months

Interviews at end-of-treatment and 3 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence

Trial Overview The study tests 'Healing Within,' a program tailored for these women to help them stop smoking. It involves an 8-week course with interviews before starting, after finishing, and three months later to check its effectiveness and impact on alcohol/drug use.

How Is the Trial Designed?

Group I: Healing Within Experimental Treatment 1 Intervention

A culturally-tailored, trauma-informed group intervention to support smoking cessation by leveraging Lakota values, mindfulness, and a storytelling approach.

Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence is already approved in United States for the following indications:

Approved in United States as Healing Within for:

• Smoking cessation for American Indian women experiencing intimate partner violence

Who Is Running the Clinical Trial?

Black Hills Center for American Indian Health

Lead Sponsor

Trials

2

Recruited

200+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Published Research Related to This Trial

The study tested a Culturally-Tailored Treatment (CTT) for smoking cessation among 103 adult American Indian/Alaska Native smokers, combining varenicline with culturally relevant counseling, but found no significant differences in smoking cessation rates compared to Standard Treatment.

Overall, the 6-month abstinence rate was 20% for the entire group, with a higher responder-only rate of 42%, indicating that while the CTT did not outperform standard methods, it represents an important step in culturally relevant health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Culturally-Tailored Smoking Cessation for Adult American Indian Smokers: A Clinical Trial. Smith, SS., Rouse, LM., Caskey, M., et al.[2022]

The review identified 34 articles that emphasize the importance of creating culturally safe environments in health care and social services for Indigenous families affected by family violence.

Key recommendations include focusing on individual and community healing, as well as advocating for systemic changes that center Indigenous perspectives and address the historical causes of family violence, such as colonization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indigenous Cultural Safety in Recognizing and Responding to Family Violence: A Systematic Scoping Review. Allice, I., Acai, A., Ferdossifard, A., et al.[2023]

Native Americans have the highest smoking rates among ethnic groups in the U.S. (41%), leading to disproportionately high death rates from tobacco-related diseases, highlighting a significant public health issue.

A collaborative effort to develop a culturally tailored smoking cessation program revealed key modifications needed for effectiveness, such as incorporating traditional tobacco practices, using culturally relevant materials, and employing Native facilitators for support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Tobacco has a purpose, not just a past": Feasibility of developing a culturally appropriate smoking cessation program for a pan-tribal native population. Daley, CM., James, AS., Barnoskie, RS., et al.[2019]

The Intertribal Talking Circle intervention was developed to address high rates of substance use among American Indian adolescents, focusing on alcohol, marijuana, and prescription medications as priority concerns identified by community partnership committees.

Cultural tailoring of the intervention, including the incorporation of local customs and language, was essential for its relevance and effectiveness, highlighting the importance of Indigenous cultures in designing substance use prevention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Formative Research and Cultural Tailoring of a Substance Abuse Prevention Program for American Indian Youth: Findings From the Intertribal Talking Circle Intervention. Baldwin, JA., Lowe, J., Brooks, J., et al.[2022]

The All Nations Breath of Life smoking cessation program, developed using a community-based participatory research approach, shows promise in improving quit rates among American Indians, who face the highest smoking rates and lowest quit rates of any ethnic group.

Preliminary data indicate a 65% quit rate at the end of the program and a 25% quit rate six months later, suggesting the program's effectiveness in supporting long-term cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

All Nations Breath of Life: using community-based participatory research to address health disparities in cigarette smoking among American Indians. Daley, CM., Greiner, KA., Nazir, N., et al.[2022]

Tobacco smoking during pregnancy is linked to serious health risks, but it is a behavior that can be changed, especially among Aboriginal and Torres Strait Islander women who face unique challenges.

The paper emphasizes the need for a culturally relevant, women-centered, and trauma-informed smoking cessation program tailored to the specific social and economic barriers faced by these communities in Western Australia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Approach to Transforming Smoking Cessation Practice for Pregnant Aboriginal Women and Girls Living in the Pilbara. Wyndow, P., Walker, R., Reibel, T.[2020]

A study involving 25 Aboriginal women revealed that smoking is often used as a coping mechanism for stress and trauma, highlighting the need for culturally relevant support in smoking cessation programs.

Women who successfully quit smoking did so when they found personal motivation or alternative lifestyles, emphasizing the importance of community support and safe spaces for discussions about health and smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Aboriginal Maternal Health by Strengthening Connection to Culture, Family and Community. Wyndow, P., Clifton, E., Walker, R.[2021]

In a study comparing 81 pregnancies among Indigenous people to 358 pregnancies among non-Indigenous people, it was found that 45.7% of Indigenous pregnancies involved smoking, which is more than three times the 11.2% prevalence in the non-Indigenous group.

Despite similar rates of uptake for smoking cessation interventions, Indigenous pregnant individuals were significantly less likely to quit smoking, indicating a need for tailored cessation strategies that address specific barriers faced by this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking Behaviors Among Indigenous Pregnant People Compared to a Matched Regional Cohort. Rusk, AM., Giblon, RE., Chamberlain, AM., et al.[2023]

A survey of 1,369 American Indian health clinic users revealed that smoking rates among Indian women are notably high, especially among single and divorced individuals, with 40.4% and 42% smoking rates respectively, compared to 34.4% for married women.

Most former smokers (79.9%) quit 'cold turkey', but less than half of current smokers expressed a willingness to quit in the near future, highlighting the need for tailored smoking cessation programs that address the specific demographic and behavioral characteristics of Indian women smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of American Indian women cigarette smokers: prevalence and cessation status. Hodge, FS., Casken, J.[2017]

Despite high awareness of the negative health effects of tobacco, many American Indian and Alaska Native participants only recognized risks associated with heavy use, overlooking the dangers of lighter consumption, which is more prevalent in their communities.

Most participants were reluctant to endorse tobacco cessation treatments, highlighting the need for targeted health promotion messaging that resonates with low-tobacco users and utilizes success stories from former tobacco users within the AI/AN community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of the PEN-3 Model to Tobacco Initiation, Use, and Cessation Among American Indian and Alaska Native Adults. Hiratsuka, VY., Trinidad, SB., Avey, JP., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07013968

Healing Within: Mindfulness Smoking Cessation Intervention Smoking prevalence among women who have experienced IPV is as high as 51% to 70%. American Indian women, including Northern Plains Tribal women, experience the ...

2. trialx.com trialx.com/clinical-trials/listings/310980/smoking-cessation-intervention-for-american-indian-women-experiencing-intimate-partner-violence/

Smoking Cessation Intervention for American Indian Women ... The goal of this project is to refine and test a culturally-tailored smoking cessation intervention for American Indian women who have experienced intimate ...

3. medicine.yale.edu medicine.yale.edu/news-article/sullivan-co-lead-of-healing-within-smoking-cessation-intervention-for-american-indian-women-experiencing-intimate-partner-violence/

Sullivan Co-Lead of Healing Within - Yale School of Medicine Sullivan Co-Lead of Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence. July 14 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3117716/

Culturally-Tailored Smoking Cessation for American Indians The program was tailored to the California AI/AN community and had a 5.7% quit rate at 18-month follow-up for the intervention group versus a 3.1% quit rate for ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1049386725000039

Smoking Cessation Programs for Women in Non- ... We aimed to systematically review the literature on smoking cessation programs for women outside reproductive contexts to assess their effectiveness and how ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06357767

Smoking Cessation Intervention for American Indian ... The goal of this project is to refine and test a culturally-tailored smoking cessation intervention for American Indian women who have experienced intimate ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4788464/

Culturally-Tailored Smoking Cessation for Adult American ... This collaborative, community-engaged project developed and tested a Culturally-Tailored Treatment (CTT) for American Indian/Alaska Native (AI/AN) smokers.

8. medicine.yale.edu medicine.yale.edu/news-article/nih-grant-indigenous-ipv-smoking-cessation/

Collaboration on NIH grant between Sullivan, Nez Henderson ... A mindfulness-based, culturally-tailored smoking cessation intervention for Indigenous women who experience intimate partner violence (IPV).