Smoking cessation and harm reduction: a systematic overview of ongoing, randomized controlled trials

Area of Science:

• Public Health
• Clinical Trials Research
• Tobacco Dependence Treatment

Background:

• Smoking cessation remains a critical public health challenge.
• Ongoing research focuses on randomized controlled trials (RCTs) for smoking cessation and harm reduction.
• This review assesses adherence to German S3 guidelines for tobacco dependence.

Purpose of the Study:

• To examine ongoing RCTs for smoking cessation and harm reduction.
• To evaluate adherence to German S3 guidelines for tobacco dependence.
• To identify research gaps and neglected aspects in tobacco dependence treatment.

Main Methods:

• Systematic search of the International Clinical Trials Registry Platform for ongoing RCTs.
• Utilized PICOS-scheme focusing on general population, biochemical verification, psychological counseling, telemedicine, and nicotine replacement therapy/smoking cessation medication or electronic nicotine delivery systems.
• Excluded completed, terminated, unknown, or withdrawn trials.

Main Results:

• Identified 30 ongoing RCTs, predominantly in North America.
• Trials often target socioeconomically disadvantaged populations; few focus on cancer survivors or those with smoking-related diseases.
• Nicotine replacement therapy/medication is common; motivational interviewing is the most frequent psychotherapeutic intervention. Electronic nicotine delivery systems are underrepresented (4 trials).

Conclusions:

• Urgent need for more RCTs on electronic nicotine delivery systems and tailored psychotherapeutic interventions.
• Expanding trial locations beyond North America and standardizing registry reporting are essential for global applicability.
• Future research should investigate long-term risks/benefits of electronic nicotine delivery systems, especially in high-risk groups, to inform guidelines.