Harm-Reduction Products for Smoking

Overseen By Janet Audrain-McGovern, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Must not be taking: Smoking cessation medication

Disqualifiers: Substance abuse, Excessive alcohol, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different smoking alternatives can change smoking habits for those not ready to quit. Participants will try either harm-reduction products like e-cigarettes, IQOS, or ONP, or a more traditional nicotine patch and lozenge combo (medicinal nicotine sampling). The trial aims to determine which method more effectively influences smoking behavior and why. It suits smokers who have been smoking at least five cigarettes a day for six months, aren't using other nicotine products, and aren't planning to quit soon. As an unphased trial, it provides a unique opportunity to explore new ways to manage smoking habits without the pressure to quit immediately.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those using smoking cessation medications or regularly using other nicotine products. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that products like e-cigarettes (ECIGs) and heated tobacco products (such as IQOS) can be safer than smoking regular cigarettes. Switching to these alternatives has been linked to lower health risks, suggesting they might be better for health than traditional smoking.

Studies also indicate that people generally tolerate heated tobacco products and e-cigarettes well. However, these products are not yet approved by the FDA for quitting smoking, and their long-term safety is still under investigation.

For those considering joining a trial with these products, it is important to weigh the potential benefits and risks. While they might be less harmful than regular cigarettes, understanding how the body reacts to them is crucial. Consulting a healthcare provider for personalized advice is always recommended. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for smoking cessation, like nicotine patches and lozenges, provide a steady dose of nicotine to ease withdrawal symptoms. However, researchers are excited about harm-reduction products because they introduce a novel approach by allowing smokers to sample alternative nicotine delivery systems like e-cigarettes (ECIGS), heated tobacco products (IQOS), and oral nicotine pouches (ONPS). These products mimic the sensory and behavioral aspects of smoking, which might make quitting easier for some individuals. By providing a personalized experience where participants can choose their preferred product, these treatments aim to reduce harm by offering less harmful alternatives to traditional smoking while still addressing nicotine cravings.

What evidence suggests that this trial's treatments could be effective for smoking behavior?

Research has shown that products like electronic cigarettes (ECIGs) and heated tobacco products (HTPs) can help people reduce smoking. One study found that over two-thirds of participants smoked fewer cigarettes after trying ECIGs. Another study demonstrated that using HTPs led to smoking fewer or no regular cigarettes. In this trial, participants in the Harm Reduction Products (HRP) arm will try and rate ECIGs, IQOS, and ONPs, receiving a 4-week supply of their preferred product. These products are designed to be less harmful than traditional cigarettes and provide nicotine in a way that might assist smokers who aren't ready to quit completely. Meanwhile, participants in the Nicotine Patch and Lozenge (NPL) arm will try a nicotine patch and lozenge, receiving a 4-week supply for the sampling period. This method could be a helpful step for those not motivated to stop smoking entirely. ^{2 6 7 8 9}

Who Is on the Research Team?

Janet Audrain-McGovern, Ph.D.

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for individuals who smoke and are not currently motivated to quit. Participants will be chosen randomly to try either harm-reduction products like e-cigarettes, IQOS, or oral nicotine products, or a control condition with nicotine patches and lozenges.

Inclusion Criteria

Able to communicate fluently in English (i.e., speaking, writing, and reading)

Have a carbon monoxide (CO) greater than or equal to 10 ppm

Not using any forms of nicotine regularly other than cigarettes

Exclusion Criteria

Regular use of nicotine-containing products other than cigarettes (e.g., chewing tobacco, snuff, snus, cigars, e-cigs, IQOS, ONPS, etc.)

Current or impending (during the study period) enrollment or plans to enroll in a smoking cessation program

Provide a CO breath test reading less than 10 ppm at Intake

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Product Selection and Sampling

Participants try and select harm-reduction products or are assigned to medicinal nicotine control, followed by a 4-week starter product regimen

4 weeks

3 virtual visits for HRP group, 1 virtual visit for NPL group

Follow-up

Participants are monitored for smoking behavior changes, including smoking abstinence and reduction, at 3-month and 6-month intervals

29 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Harm-Reduction Sampling
• Medicinal Nicotine Sampling

Trial Overview The study compares the effects of choosing between three harm-reduction smoking products against using medicinal nicotine (patches + lozenges) on smoking behavior over six months. It also examines why these methods work and for whom they're most effective.

How Is the Trial Designed?

Group I: Harm Reduction Products (HRP) Experimental Treatment 1 Intervention

Participants randomized to HRP will try and rate ECIGS, IQOS, and ONPS during 3 virtual visits, and receive a 4-week supply of their preferred HRP (ECIGS, IQOS, or ONPs) for the sampling period.

Group II: Nicotine Patch and Lozenge (NPL) Active Control 1 Intervention

Participants randomized to NPL will try a nicotine patch and nicotine lozenge during 1 virtual lab visit and will receive a 4-week supply of nicotine patches and lozenges for the sampling period.

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11755284/

Harm reduction associated with heated tobacco products We conducted a systematic review and meta-analysis of randomised studies in humans comparing the outcomes of switching to heated tobacco products (HTPs) ...

2. harmreductionjournal.biomedcentral.com harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-024-01000-2

A reduced exposure heated tobacco product was introduced ... This study demonstrates reduction or elimination of combustible cigarette smoking while adults were using HTPs and some increased smoking after market removal.

3. ajpmonline.org ajpmonline.org/article/S0749-3797%252810%252900792-0/fulltext

Electronic Cigarettes As a Smoking-Cessation Tool More than two thirds of respondents (66.8%) reported having reduced the number of tobacco cigarettes they smoked per day after trying e-cigarettes, and nearly ...

4. tobaccocontrol.bmj.com tobaccocontrol.bmj.com/content/30/e1/e1

Co-optation of harm reduction by Big Tobacco A review of the efficacy and effectiveness of harm reduction strategies for alcohol, tobacco and illicit drugs. Drug Alcohol Rev 2006;25:611–24.doi:10.1080 ...

5. accpjournals.onlinelibrary.wiley.com accpjournals.onlinelibrary.wiley.com/doi/full/10.1002/jac5.70092

Evidence Regarding E‐Cigarettes as a Harm Reduction ... Current evidence suggests e-cigarettes may be efficacious as a harm reduction tool for those not yet ready to completely abstain from nicotine.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8733777/

Heated tobacco products for smoking cessation and reducing ... Heated tobacco products (HTPs) are designed to heat tobacco to a high enough temperature to release aerosol, without burning it or producing smoke.

7. publichealthlawcenter.org publichealthlawcenter.org/sites/default/files/resources/Heated-Tobacco-Products-Myth-of-Harm-Reduction.pdf

E-CIGS & HEATED TOBACCO PRODUCTS This fact sheet looks at the tobacco industry's history of using harm reduction in its marketing tactics, including its promotion of e-cigarette ...

8. aafp.org aafp.org/pubs/afp/issues/2023/0500/letter-patients-who-smoke.html

Harm Reduction for Patients Who Smoke The evidence clearly shows that by switching from smoking to vaping, people in this group had significantly reduced risks to their health.

9. sciencedirect.com sciencedirect.com/science/article/pii/S235285322200027X

Perceived harm of heated tobacco products, e-cigarettes ... The aim of this study was to explore relative harm perceptions of HTPs, e-cigarettes, and nicotine replacement therapy (NRT) relative to conventional cigarettes ...