IVR Therapy for Smoking Cessation and Pain

(PASS-IVR Trial)

Overseen By Lori A Bastian, MD MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Dementia, Psychosis, Terminal illness, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help Veterans quit smoking while managing chronic pain. It uses an Interactive Voice Response (IVR) phone system to provide support and advice, along with medications like nicotine patches or gum. This approach, known as PASS-IVR, will be compared to usual care, which includes counseling and optional medication. Veterans who currently smoke, are willing to quit, and have experienced significant chronic pain for over 90 days are ideal candidates for this trial. As an unphased trial, it offers Veterans a unique opportunity to access innovative support methods while contributing to valuable research.

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 healthcare provider.

What prior data suggests that this IVR therapy is safe for smoking cessation and pain?

Research shows that the PASS-IVR treatment, which combines smoking cessation support with pain management strategies and nightly phone check-ins, appears promising for Veterans with chronic pain who smoke. In past studies on similar treatments, participants generally found the approach manageable.

The treatment also includes 12 weeks of medication, such as nicotine patches, lozenges, gum, and possibly varenicline, all tailored to individual smoking habits. These medications are commonly used and safe for most people when used correctly. Side effects are usually mild and temporary, such as minor skin irritation from patches or nausea from varenicline, and are well-known and manageable.

Although detailed safety data specific to PASS-IVR is not yet available, the components of the treatment have a strong safety record. Participants can feel reassured knowing this approach builds on proven methods that have been effective and safe for many others. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PASS-IVR treatment because it uniquely combines telehealth technology with proven smoking cessation counseling, enhanced by strategies for managing pain. Unlike traditional treatments that focus solely on quitting smoking, PASS-IVR addresses both smoking and pain management, making it more comprehensive. Additionally, the use of nightly Interactive Voice Response (IVR) calls offers continuous support, which could lead to better adherence and outcomes. This method also personalizes pharmacotherapy based on individual smoking habits, potentially increasing its effectiveness.

What evidence suggests that PASS-IVR is effective for smoking cessation and pain?

Research has shown that Interactive Voice Response (IVR) can help people quit smoking. One study found that IVR increased the number of successful quitters and improved their health. People who used similar methods, such as cognitive behavioral interventions (CBI) combined with smoking cessation tools, were more likely to avoid cigarettes. In this trial, participants in the PASS-IVR arm will receive a proactive telehealth intervention that combines IVR and CBI, which can address both smoking and pain. This makes it a promising option for Veterans with chronic pain. These findings suggest that the PASS-IVR treatment might effectively aid in quitting smoking and managing pain. ^{1 2 6 7 8}

Who Is on the Research Team?

Lori Anne Bastian, MD MPH

Principal Investigator

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Are You a Good Fit for This Trial?

This trial is for Veteran smokers who experience chronic pain and are interested in quitting smoking. Participants should be willing to receive telephone-based support.

Inclusion Criteria

Current tobacco use

I am willing to try to quit smoking.

Enrolled Veteran at VACHS

Exclusion Criteria

Lack of telephone access

Pregnancy

Provider advising against exercise

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the PASS-IVR intervention, which includes smoking cessation counseling, behavioral approaches for coping with pain, and nightly IVR calls. Pharmacotherapy is offered for 12 weeks.

12 weeks

Telehealth sessions and nightly IVR calls

Follow-up

Participants are monitored for cigarette abstinence rates and pain interference at 6 and 12 months.

12 months

Follow-up assessments at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• PASS-IVR

Trial Overview The study tests a phone-delivered cognitive behavioral intervention (CBI) using Interactive Voice Response (IVR) to help Veterans quit smoking, comparing it with the usual treatment methods.

How Is the Trial Designed?

Group I: Treatment as Usual Experimental Treatment 1 Intervention

Treatment as usual includes referral to the local smoking cessation clinic where Veterans may select a virtual individual or group based cognitive behavioral smoking cessation program with a trained psychology intern, postdoctoral fellow or staff psychologist. In conjunction, Veterans are encouraged but not required, by clinic staff, to connect with the VA Quitline and the VA's Annie text-messaging service to support their quit. Veterans are strongly encouraged to consider pharmacotherapy (e.g., NRT patches and one of two rescue methods such as nicotine lozenge or gum or varenicline). The NRT dose and delivery route will be tailored to the number of cigarettes smoked per day (using an established protocol - interested Veterans will be offered a telemedicine consult for this service

Group II: PASS-IVR Experimental Treatment 1 Intervention

An intervention that includes a proactive telehealth intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain, and nightly Interactive Voice Response (IVR) calls. Veterans in PASS-IVR will also be offered 12-weeks of pharmacotherapy (e.g., NRT patches and one of two rescue methods such as nicotine lozenge or gum or varenicline) via telemedicine consult. The NRT dose and delivery route will be tailored to the number of cigarettes smoked per day (using an established protocol).

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

This randomized trial will compare the effectiveness of real-time video counselling, telephone counselling, and written materials for smoking cessation among regional and remote residents in New South Wales, Australia, with a focus on achieving smoking abstinence.

The study will assess the primary outcome of 7-day point prevalence abstinence at 13 months post-baseline, potentially demonstrating that video counselling could be a viable and effective alternative to traditional methods for helping people quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised trial of real-time video counselling for smoking cessation in regional and remote locations: study protocol. Tzelepis, F., Wiggers, J., Paul, CL., et al.[2019]

In a study involving 1785 participants, the standard quitline treatment was highly effective, with a 30-day quit rate of 61.2% at 12 months, demonstrating that traditional methods remain successful in helping smokers quit.

Adding an interactive voice response (IVR) system for relapse risk assessments did not significantly improve quit rates compared to standard treatment, indicating that while the IVR identified at-risk individuals, it did not enhance overall effectiveness in preventing relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial to prevent smoking relapse among recently quit smokers enrolled in employer and health plan sponsored quitlines. McDaniel, AM., Vickerman, KA., Stump, TE., et al.[2019]

In a study involving 725 smokers over a 6-month period, only 33.8% engaged with a trained tobacco treatment specialist (TTS) through asynchronous messaging, indicating low participant engagement.

Despite the feasibility of using asynchronous counseling to provide evidence-based support, there was no significant association between the frequency of TTS communication and smoking cessation outcomes, suggesting that future research should focus on increasing engagement and combining this method with other cessation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secure Asynchronous Communication Between Smokers and Tobacco Treatment Specialists: Secondary Analysis of a Web-Assisted Tobacco Intervention in the QUIT-PRIMO and National Dental PBRN Networks. Sadasivam, RS., Kamberi, A., DeLaughter, K., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8391053/

Pain and smoking study (PASS): A comparative effectiveness ... PASS utilizes an innovative smoking and pain intervention to promote smoking cessation among Veterans with chronic pain. Baseline ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S245186542100140X

A comparative effectiveness trial of smoking cessation ... The goals of the study were to: 1) evaluate the impact of smoking cessation plus CBI (SMK-CBI) on cigarette abstinence rates (primary outcome) among Veterans ...

3. withpower.com withpower.com/trial/ivr-therapy-for-smoking-cessation-and-pain-e6e2f

IVR Therapy for Smoking Cessation and Pain (PASS- ... This study will use Interactive Voice Response (IVR) to optimize the intervention's effectiveness for smoking cessation among Veteran smokers with chronic pain.

4. bmjopen.bmj.com bmjopen.bmj.com/content/14/7/e081972

Interactive voice response (IVR) for tobacco cessation Overall, IVR was effective at increasing abstinence rates and encouraging positive health outcomes for tobacco cessation. However, several significant gaps ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9472044/

Proactive Electronic Visits for Smoking Cessation and Chronic ... At 3 months, all cessation outcomes except for 24-hour quit attempts favored the e-visit, with significant effects for cessation medication use ...

6. reporter.nih.gov reporter.nih.gov/project-details/10197054

Promoting Smoking Cessation in Lung Cancer Screening ... The primary endpoint is biochemically confirmed 7-day abstinence 12 months after screening. Based on prior trials of opt-out treatment and our pilot data, the ...

7. highergov.com highergov.com/contract-opportunity/da10-pass-ivr-36c24125q0040-r-45c0e/

Pass IVR 36C24125Q0040 Specific tasks for Enhancing an Intervention for Smokers with Chronic Pain using IVR: A Randomized Clinical Trial of Smoking Cessation ...

8. hsrd.research.va.gov hsrd.research.va.gov/research/abstracts.cfm?Project_ID=2141709781

IIR 22-070 – HSR Study - VA Health Systems Research More than 50% of patients with chronic pain smoke and standard smoking cessation interventions are largely ineffective for them – in part because pain is a ...