Exenatide once weekly for smoking cessation: study protocol for a randomized clinical trial
| Autor: | Charles Green, Janet C. Meininger, Luba Yammine, Thomas R. Kosten, Paul M. Cinciripini, Jennifer A. Minnix, Thomas F. Newton |
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| Rok vydání: | 2018 |
| Předmět: |
Counseling
medicine.medical_treatment Treatment outcome Craving law.invention 0302 clinical medicine Randomized controlled trial law Glucagon-Like Peptide 1 Study Protocol Clinical Trial 030212 general & internal medicine Young adult withdrawal Glucagon-like Peptide-1 Agonists General Medicine Middle Aged Substance Withdrawal Syndrome Treatment Outcome medicine.symptom medicine.drug Research Article Adult medicine.medical_specialty Adolescent Administration Cutaneous Drug Administration Schedule smoking 03 medical and health sciences Young Adult Double-Blind Method Internal medicine Exenatide once weekly medicine Humans Aged business.industry Venoms smoking abstinence glucagon-like peptide-1 Delayed-Action Preparations Smoking cessation Exenatide Smoking Cessation business Peptides 030217 neurology & neurosurgery study protocol |
| Zdroj: | Medicine |
| ISSN: | 1536-5964 |
| Popis: | Background Cigarette smoking is the greatest preventable cause of morbidity and premature mortality in the United States. Approved pharmacological treatments for smoking cessation are marginally effective, underscoring the need for improved pharmacotherapies. A novel approach might use glucagon-like peptide-1 (GLP-1) agonists, which reduce alcohol and drug use in preclinical studies. GLP-1 is produced in the intestinal L-cells and in the hindbrain. The peptide maintains glucose homeostasis and reduces food intake. Several GLP-1 agonists are used clinically to treat type 2 diabetes and obesity, but none have been tested in humans to reduce smoking. Aims We will examine whether extended-release exenatide reduces smoking, craving, and withdrawal symptoms, as well as cue-induced craving for cigarettes. Methods We will enroll prediabetic and/or overweight treatment seeking smokers (n = 90) into a double-blind, placebo-controlled, randomized clinical trial. Participants will be randomized in a 1:1 ratio to receive exenatide or placebo. All participants will receive transdermal nicotine replacement therapy (NRT) and behavioral counseling. Abstinence from smoking (verified via expired CO level of ≤5 ppm), craving (Questionnaire of Smoking Urges score), and withdrawal symptoms (Wisconsin Scale of Withdrawal Symptoms score) will be assessed weekly during 6 weeks of treatment and at 1 and 4 weeks posttreatment. Cue-induced craving for cigarettes will be assessed at baseline and at 3 weeks of treatment following virtual reality exposure. Expected outcomes We hypothesize that exenatide will increase the number of participants able to achieve complete smoking abstinence above that achieved via standard NRT and that exenatide will reduce craving and withdrawal symptoms, as well as cue-induced craving for cigarettes. |
| Databáze: | OpenAIRE |
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