Options Study Completes Recruitment

UW-CTRI has completed recruitment for the Options Study. Participants in Madison and Milwaukee temporarily switch from just smoking to alternative products. These products include Juul e-cigarettes or cigarettes with very low nicotine (VLN) content.

The study team surpassed its goal of enrolling 200 participants.

JaniceOne of those participants is Janice, who saw an ad on Facebook for the study. “I thought, ‘You know what? I’m going to give it a try.’ So I signed up. Meeting the first time was very helpful. It explained what was going on.”

Janice met with Health Counselor Chris Ripley, who helped randomize Janice to receive the Juul vape product plus the patch.

During the first week of the Options study, Janice was allowed to smoke, so she did. She had smoked a pack a day for years. For the second week of the study, she used the vape device and nicotine patches.

“I haven’t had a cigarette since. I was amazed, in a week!”

All study participants were people who smoke and didn’t want to quit but were willing to switch from their cigarettes to something new for a week. The four weeks of the study had different goals:

  • Week 1: Try out the study product they were randomly assigned to use: Juul e-cigarettes, VLN cigarettes or no alternative product. They could smoke their own cigarettes as usual.
  • Week 2 (Switch Week): Don’t smoke their own cigarettes but use a patch (active or placebo) and their assigned study product.
  • Week 3: Smoke their own cigarettes and use their study product as much as they want.
  • Week 4 (Switch Week): Don’t smoke their own cigarettes but use a patch (if they had an active patch with nicotine in Week 2 they now had a placebo patch with no nicotine or vice versa) and their assigned study product.

The Options study has enrolled more than the target of 200 people who smoke but are not ready to quit at this time. Participants have been randomly assigned to switch to: Juul + nicotine patch for a week, and Juul + placebo patch for a week or LNCs + patch for a week, and LNCs + placebo patch for a week or Just nicotine patch for a week, and just placebo patch for a week

Researchers will examine how well Juul or low-nicotine cigarettes can substitute for regular smoking, how nicotine patches factor into it and why.

The Options Study is made possible by a $1.4 million three-year grant from the National Cancer Institute and Food and Drug Administration to UW-CTRI.

While it’s too early to report findings, one anecdotal note is that participants didn’t seem to like the taste of VLN, said UW-CTRI Co-Research Director and Options Study Principal Investigator Dr. Megan Piper. She said it will be interesting to see if the public likes them, now that the VLN King and VLN King Menthol have been approved for testing in the Chicago area.

“This study was a wonderful example of what we can achieve here at UW-CTRI,” Piper said. “The study itself used innovative technology (such as the Insight app to collect daily reports of what products people used and the Intelliquit app to assess total nicotine equivalents in urine samples). This addressed the important question of: Can we get people who smoke who aren’t interested in quitting to use a substitute non-combustible product? It took an inordinate amount of teamwork and dedication during COVID to conduct these in-person study visits. I can’t thank the team enough for their efforts.”

That team included Kate Kobinsky, who managed the study through the COVID pandemic and beyond. Health Counselors included Chris Ripley, Mari MarquezTess KubaRenae Borkowski, Cassandra Astemborski, Taylor Pinkerton, and Justeena Jojo with team supervisors Holly Prince and Meg Feyen, and key contributions from Kathleen Cantu, T.Jay Christenson, Sally Steward-Townsend, and Marie Larson. These team members worked in the office during the COVID pandemic prior to vaccines.

“I want to thank everyone who contributed,” said UW-CTRI Director Dr. Michael Fiore, “and especially those who worked in the office during the pandemic to help our study participants and keep the research going.”

Milwaukee UW-CTRI Options Team from Left: Sally Steward-Townsend, Mari Marquez, Tess Kuba, Renae Borkowski, T.Jay Christenson. 
Milwaukee UW-CTRI Options Team from Left: Sally Steward-Townsend, Mari Marquez, Tess Kuba, Renae Borkowski, T.Jay Christenson.
Madison UW-CTRI Options Team from Left: Katie Greiber, Chris Hollenback, Megan Piper, Julia Matthews, Kathleen Cantu, Holly Prince, Kate Kobinsky, Lisa Rogers, Chris Ripley, Marie Larson. Not pictured but not forgotten: Dr. Douglas Jorenby, Kari Giacalone, Adam Nunez, Jonah Stankovsky, Katrina Bundy, Todd Hayes-Birchler, Cole Stodola, Ryan Westbrook, Miranda Kapfhammer, Taylor Pinkerton, Cassandra Astemborksi, and Justeena Jojo.

Dr. Douglas Jorenby was the co-Investigator on the grant who helped guide the science. Kari Giacalone and Katrina Bundy worked on crucial logistics, including study safety. Jonah Stankovsky, Julia Matthews, Adam Nunez, and Todd Hayes-Birchler provided technological and data expertise. Students Cole Stodola, Ryan Westbrook and Miranda Kapfhammer also assisted the study team.

Lisa Rogers, Katie Greiber and Chris Hollenback helped to recruit participants throughout the pandemic, through changes in how social media ads worked, and beyond. Janice was glad they did.

“The study was really helpful,” Janice said. “I surprised myself. I wasn’t sure it was going to work, and it did. I never had another cigarette again. I would recommend this to anyone.”

She said the combination of the sensation of tobacco from Juul plus the nicotine from Juul and the patch helped her quit smoking. Knowing she had to blow a breath test was a motivating factor too, she said. Now, she’s vaping 10-12 times a day, and wants to use the nicotine patches again to try to quit vaping. Either way, she feels better already.

“Oh, absolutely. When I was smoking, I was coughing terribly. I don’t do that at all anymore. I feel better about myself. My children do as well, they are so happy I’m not smoking cigarettes anymore. My grandchildren, too.”