Exenatide Once Weekly for Smoking Cessation

What Was Tested

The trial (phase 1, phase 2) is built around Exenatide.

The purpose of this study is to identify a potential new treatment for smoking cessation.

It had two arms (groups): Exenatide plus NRT plus counseling (experimental) and Placebo plus NRT plus counseling (placebo comparator).

Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling.

Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling.

The registry classes the interventions as behavioral and drug.

Who Took Part

The registry lists 84 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Be English-speaking volunteers who desire to quit smoking and are willing to make a quit attempt during the course of the study;. Have smoked ≥10 cigarettes a day for at least one year and provide a breath carbon monoxide (CO) ≥10 ppm;. Have a negative pregnancy test, if female of childbearing potential;. Not currently using any therapy for glycemic control (either injectable \[i.e. insulin\] or oral agents);. Have vital signs as follows: resting pulse between 50 and 95 bpm, BP between 90-150 mmHg systolic and 45-95 mmHg diastolic;.

The full record lists 8 inclusion and 14 exclusion criteria; among the exclusions: individuals rated as moderate (9-16) to high (17 or greater) on suicidality as assessed by module b of the mini; have personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2;; have type 1 diabetes mellitus;.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

The Exenatide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Exenatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2016-07 with completion listed for 2020-01-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm (time frame: 6 weeks). Post-quit Craving as Assessed by the Questionnaire of Smoking Urges (time frame: 6 weeks). Withdrawal Symptoms as Assessed by the Wisconsin Smoking Withdrawal Scale (time frame: 6 weeks).

It also tracked 4 secondary outcomes, for example Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm, Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm, Post-quit Craving as Assessed by the Questionnaire of Smoking Urges and Post-quit Craving as Assessed by the Questionnaire of Smoking Urges.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Exenatide in 84 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Exenatide compound page, all human trials.