CAMI for Substance Use

(CAMI-HI Trial)

Not currently recruiting at 1 trial location

Overseen By Christina S Lee, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University Charles River Campus

Disqualifiers: Psychotic symptoms, Cognitive impairment, 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: 1

Duration: 2 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a culturally adapted form of motivational interviewing (CAMI) that addresses immigration-related stress, such as stigma and social isolation, among Latinx heavy drinkers. The goal is to determine if CAMI can reduce alcohol-related harms and improve mental health compared to standard care. Participants will receive either a CAMI session with a follow-up booster or standard care. Suitable candidates are Latinx individuals, first or second-generation immigrants, who have engaged in binge drinking in the past month. The research aims to assess the effectiveness and practicality of CAMI in real-world primary care settings. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance mental health care for the Latinx community.

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 would be best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that CAMI is safe for use in addressing substance use among Latinx individuals?

Research has shown that Culturally Adapted Motivational Interviewing (CAMI) is generally well-received by individuals with substance use issues. One study found that CAMI helped reduce alcohol-related problems among heavy-drinking Hispanics over a year, with participants experiencing no major negative side effects from the treatment.

Another study examined the practicality and acceptability of CAMI and found that participants reacted positively. This suggests that CAMI is not only safe but also appreciated by those seeking help for substance use issues.

Although detailed safety data is limited, these findings suggest that CAMI is a safe and potentially effective option for individuals dealing with substance use, particularly in the Latinx community. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CAMI (Culturally Adapted Motivational Interview) for substance use because it directly addresses the cultural factors influencing addictive behaviors, which many standard treatments do not. Unlike traditional approaches that may not consider cultural contexts, CAMI offers a personalized, single-session intervention that focuses on the root causes of addiction, followed by a booster session to reinforce the initial counseling. This culturally sensitive method has the potential to increase engagement and effectiveness in diverse populations, offering a fresh perspective on addiction treatment.

What evidence suggests that CAMI is effective for reducing substance use among Latinx individuals?

Research has shown that Culturally Adapted Motivational Interviewing (CAMI), which participants in this trial may receive, effectively reduces alcohol-related problems among Latinx individuals, particularly those facing high levels of discrimination. In past studies, CAMI significantly reduced anxiety and depression symptoms one year after the session compared to regular motivational interviewing. In this trial, participants in the CAMI arm will receive a single 75-minute session that explores the reasons behind addictive behavior, followed by a booster session two months later. This culturally tailored method encourages motivation to change drinking and drug use habits, leading to better participation in treatment and improved results. Studies have demonstrated that these adaptations enhance access to and effectiveness of alcohol treatment for Latinx communities. ^{2 4 5 6 7}

Who Is on the Research Team?

Christina S Lee, PhD

Principal Investigator

Boston University

Are You a Good Fit for This Trial?

This trial is for Latinx adults who are first or second-generation immigrants and heavy drinkers, defined as having 4/5 or more drinks per occasion at least once a month, or scoring high on alcohol use assessments. It's not for those in current treatment for alcohol disorders, with psychotic symptoms, cognitive impairments, or enrolled in the CCM Program for over 3 months.

Inclusion Criteria

You self-identify as Latinx.

People who have moved to this country recently or whose parents moved here recently.

I drink 4+ (women) or 5+ (men) drinks at a time, at least once a month, or have an AUDIT score of 8+ (men) or 6+ (women).

Exclusion Criteria

You are currently experiencing symptoms of psychosis (losing touch with reality).

Currently in psychosocial treatment for alcohol use disorder

I have difficulty with memory or thinking clearly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single 75-minute CAMI session focusing on addiction behavior causes, followed by a booster session at 2 months

2 months

1 initial visit (in-person), 1 booster visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of drinking and drug use, anxiety, and depression

12 months

Regular follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• CAMI

Trial Overview The study tests CAMI (a culturally adapted motivational interviewing) against standard care to see if it reduces alcohol-related harm and improves mental health among Latinx heavy drinkers using drugs and/or alcohol. Participants will be followed up to one year after receiving CAMI from trained Community Wellness Advocates.

How Is the Trial Designed?

Group I: CAMI/CAMI booster Experimental Treatment 1 Intervention

Culturally Adapted Motivational Interview. Participants will receive a single session, 75 minute addiction counseling discussion that focuses on the causes of addictive behavior. They will receive a CAMI booster session at 2 months and standard care in a primary care setting.

Group II: Control Active Control 1 Intervention

Assessment plus standard care. Participants will complete an assessment, including measures on drinking and drug use. They will also receive standard care in a primary care setting.

CAMI is already approved in United States for the following indications:

Approved in United States as CAMI for:

• Alcohol use disorder
• Substance use disorder

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials

125

Recruited

14,100+

Brown University

Collaborator

Trials

480

Recruited

724,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

Culturally adapted motivational interviewing (CAMI) significantly reduced immigration and acculturation stress, as well as related drinking behaviors, among 149 Latinx adults over a 12-month period, indicating its efficacy as an intervention.

Participants with lower levels of acculturation and higher perceived discrimination experienced greater reductions in stress and drinking, suggesting that CAMI may be particularly beneficial for those facing more significant cultural challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Culturally adapted motivational interviewing's effects on drinking in response to immigration and acculturation stressors among Latinx adults with heavy drinking problems. Hai, AH., Lee, CS., Zhou, C., et al.[2023]

Cultural adaptations of motivational interviewing (CAMI) have been shown to enhance effectiveness in treating diverse populations, with 10 out of 17 randomized controlled trials demonstrating significant improvements in primary outcomes compared to control conditions.

The successful adaptations focused on three key dimensions—Context, Content, and Concepts—highlighting the importance of tailoring interventions to align with the cultural values and goals of clients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cultural adaptations of motivational interviewing: A systematic review. Self, KJ., Borsari, B., Ladd, BO., et al.[2023]

A clinical trial involving 57 heavy drinking Latinos showed that both culturally adapted and unadapted motivational interviewing significantly reduced heavy drinking days and drinking-related problems over 6 months, with high retention rates of 86% and 84%.

Culturally adapted motivational interviewing was particularly effective, leading to greater reductions in drinking consequences at both 2 months and 6 months, suggesting that cultural adaptation enhances the treatment's efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Culturally adapted motivational interviewing for Latino heavy drinkers: results from a randomized clinical trial. Lee, CS., López, SR., Colby, SM., et al.[2021]

A pilot study involving 25 participants from a Latino immigrant community showed that a culturally adapted motivational interviewing approach (CAMI) was well-received, with high engagement and satisfaction scores (M = 3.58 on a scale of 1-4).

Participants emphasized the importance of cultural understanding in addressing their drinking behaviors, with 95% agreeing that it was crucial for effective treatment, highlighting the relevance of cultural adaptations in addiction interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cultural adaptation of motivational interviewing to address heavy drinking among Hispanics. Lee, CS., López, SR., Hernández, L., et al.[2023]

The study evaluated the effectiveness of motivational interviewing (MI) and culturally adapted motivational interviewing (CAMI) for treating Latino heavy drinkers, using the motivational interviewing treatment integrity system (MITI) to assess treatment fidelity.

The MITI showed excellent reliability in coding MI and CAMI sessions, indicating it is a reliable tool for evaluating treatment integrity, although some aspects like complex reflections and empathy ratings need further investigation for cross-cultural applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing treatment fidelity in a cultural adaptation of motivational interviewing. Lee, CS., Tavares, T., Popat-Jain, A., et al.[2021]

Motivational interviewing (MI) has been culturally adapted for Native American communities, making it more accessible and relevant for treating substance problems among these populations.

Native American treatment providers showed enthusiasm for using the adapted MI in their practices, indicating that community collaboration can enhance the effectiveness of interventions and support future clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helping Clients Feel Welcome: Principles of Adapting Treatment Cross-Culturally. Venner, KL., Feldstein, SW., Tafoya, N.[2023]

Collective Motivational Interviewing (CMI) was tested in a pilot study with 20 individuals with drug use problems and their concerned significant others, showing that CMI can effectively reduce drug use and enhance motivation for change with social support.

At the 3-month follow-up, participants demonstrated reduced drug use and strengthened social support, indicating that CMI is a promising intervention for motivating individuals with drug use issues, although the study's small sample size limits the generalizability of the results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collective Motivational Interviewing for Individuals with Drug Use Problems: A Pre-Post-Follow-Up, Uncontrolled Pilot Study. Tse, N., Tse, S., Wong, PWC.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10353888/

Culturally Adapted Motivational Interviewing's effects on ... Motivational interviewing to improve treatment engagement and outcome in individuals seeking treatment for substance abuse: A multisite effectiveness study.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714416302397

Theory of adaptation and study protocol Cultural adaptation of evidence-based treatments, such as motivational interviewing (MI), can improve access and response to alcohol treatment. However, the ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04771650

A Hybrid Effectiveness Implementation Study of Latino/ ... The CAMI is a culturally adapted motivational interview. It is a single 75 minute session that focuses on promoting motivation to change drinking and drug use ...

4. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-023-01296-0

Culturally adapted motivational interviewing with cognitive ... Culturally adapted motivational interviewing with cognitive behavior therapy and mindfulness-based relapse prevention for substance use disorder ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jcad.12505

Results from a pilot efficacy trial of a motivational ... We conducted a pilot feasibility study to examine the efficacy of a culturally adapted Group Motivational Interviewing for Teens–alternative ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5063031/

A randomized controlled trial of culturally adapted motivational ... A large, 12 month randomized prospective trial, examines the efficacy of CAMI and MI among heavy drinking Hispanics recruited from the community.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10124001/

Culturally adapted motivational interviewing with cognitive ... This study will provide evidence for feasibility and acceptability of culturally adapted manually assisted psychological interventions for individuals with SUD ...