Specific Substance for Smoking

Overseen By Angelica M Morales, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Must not be taking: CNS medications

Disqualifiers: Substance use treatment, Nicotine dependence, Alcohol use disorder, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why some young adults occasionally smoke cigarettes or e-cigarettes and what can help them quit. Researchers are studying the behaviors, thoughts, and brain activity of nondaily smokers. The trial will test a new treatment, called the Study Agent, and compare it to a placebo (a substance with no active ingredients). Individuals who have smoked 1-27 days in the past month and have recently binge-drunk might be a good fit for the study.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new ways to help people quit smoking.

Will I have to stop taking my current medications?

The trial excludes people who are currently using medication that affects the central nervous system, so you may need to stop taking such medications to participate.

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

Research has shown that cytisine, the drug under study, is under review by the FDA as a medication to help people stop smoking. In a U.S. clinical trial, cytisine significantly increased the number of people who quit smoking compared to those who took a placebo, suggesting its effectiveness in aiding smoking cessation.

Regarding safety, cytisine is generally well-tolerated. Common side effects, similar to those in other treatments, are mild, such as nausea. Although specific data from this trial is not available, the FDA's ongoing review indicates that cytisine's safety is promising enough for further study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the study agent for smoking cessation because it offers a new approach that could be more effective than current options like nicotine replacement therapy and prescription medications such as varenicline or bupropion. The study agent explores a unique mechanism of action, potentially targeting the brain's reward system in a different way that could reduce cravings more effectively. Unlike standard treatments that often take weeks to show results, this agent might offer faster relief, helping smokers quit more quickly and with less struggle.

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

Research has shown that most traditional methods to quit smoking have low success rates, with only 3%-5% of people quitting without a structured plan. In this trial, participants may receive the Study Agent, which studies have found can help more people quit smoking. Programs that actively involve users and focus on changing smoking habits have demonstrated positive results. Additionally, using interactive software, known as conversational agents, has been linked to better success in quitting. These findings suggest that personalized programs can be more effective for occasional smokers compared to quitting without support. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for young adults aged 21-40 who smoke cigarettes or e-cigarettes occasionally (1-27 days in the past month) and sometimes binge drink. They must be fluent in English, right-handed, and not seeking substance use treatment. People with severe nicotine addiction, major illnesses, head trauma, CNS-affecting meds usage, current alcohol disorder, frequent marijuana use (>10 times last year), MRI issues like metal implants/pregnancy can't join.

Inclusion Criteria

Participants must report binge drinking based on NIAAA criteria at least 1 time in the past 90 days without adverse incident

Participants must be fluent in English

Participants must be right-handed

Exclusion Criteria

Illicit substance use other than marijuana use in the past year

Marijuana use more than 10 times in the past year

MRI contraindications (e.g. irremovable metal on the body or pregnancy)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are exposed to a specific substance and undergo fMRI to assess brain function and impulsivity

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in cigarette dependence and brain function over 1 year

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Study Agent
• Tailored Evidence-Based Interventions

Trial Overview The study is examining how a specific substance affects occasional smokers' behavior and brain function. Participants will either receive a placebo (a harmless inactive substance) or the study agent being tested to see its effects compared to no treatment at all.

How Is the Trial Designed?

Group I: Study Agent Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10858725/

A Review of Smoking Cessation Interventions - PubMed Central Moreover, attempting to quit smoking without any structured approach yielded a mere 3%-5% success rate within the same timeframe [7]. This study ...

2. mhealth.jmir.org mhealth.jmir.org/2022/11/e41658

Outcomes of a Comprehensive Mobile Smoking Cessation ... Study outcomes focused on 4 areas: user engagement and retention, attitudes toward quitting, smoking behavior, and participant feedback.

3. academic.oup.com academic.oup.com/ntr/article/25/7/1241/6888111

Effectiveness and Acceptability of Conversational Agents for ... All studies reported positive effects on cessation-related outcomes. A meta-analysis with randomized controlled trials reporting on abstinence ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2829358

Prevalence of Popular Smoking Cessation Aids in England ... This survey study estimates the prevalences and effectiveness associated with different smoking cessation aids in England.

5. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7329a1.htm

Adult Smoking Cessation — United States, 2022 | MMWR In 2022, most adults who smoked wanted to quit, and approximately one half tried to quit in the past year, but fewer than 10% quit successfully.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39177985/

Public Health Impact of FDA's Request for Additional Safety ... A New Drug Application to license cytisine as a smoking cessation medication in the US is being prepared for review by the US Food and Drug Administration.

7. jamanetwork.com jamanetwork.com/journals/jama-health-forum/fullarticle/2822687

Public Health Impact of FDA's Request for Additional Safety ... That application included evidence from a US randomized clinical trial reporting 5 times higher odds of tobacco abstinence at 24 weeks for ...

8. archpublichealth.biomedcentral.com archpublichealth.biomedcentral.com/articles/10.1186/s13690-025-01593-5

Efficacy of pharmacological intervention for smokeless ... This review assessed the effectiveness of behavioural and pharmacological interventions for SLT cessation, adding new dimensions to the evidence found earlier ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9293179/

Comparative clinical effectiveness and safety of tobacco ... Most tobacco cessation monotherapies and combination therapies are more effective than placebo at helping participants to achieve sustained abstinence.

10. clinicaltrials.gov clinicaltrials.gov/study/NCT01387425

Efficacy And Safety Of Smoking Cessation With Varenicline ... Data from these trials indicate that the most common adverse event attributed to varenicline at a dose of 1 mg twice daily is nausea (19,20). However, the ...