Varenicline + Self-Change Pamphlet for Smoking, Cessation

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Medical University of South Carolina, Charleston, SC
Smoking, Cessation
Varenicline Tartrate - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Varenicline is used to treat tobacco use dependence. It helps reduce cravings for tobacco use and decreases the pleasurable effects of cigarettes and other tobacco products. Varenicline has been proven to reduce the desire to smoke cigarettes. This study aims to test whether it shows a similar benefit for individuals who vape and are interested in quitting.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Smoking, Cessation

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Week 12

Week 12
Abstinence from vaping at week 12
Number of participants Abstinent from vaping at week 12
Week 8
Abstinence from vaping at week 8
Number of participants Abstinent from vaping at week 8

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Smoking, Cessation

Side Effects for

Varenicline
28%Nausea
13%Nasopharyngitis
11%Insomnia
11%Abnormal dreams
8%Headache
8%Upper respiratory tract infection
7%Anxiety
6%Fatigue
5%Constipation
5%Irritability
0%Alcoholism
0%Vomiting
0%Myocardial infarction
0%Supraventricular tachycardia
0%Pancreatic cyst
0%Cellulitis
0%Peritonitis
0%Foot fracture
0%Thermal burn
0%Road traffic accident
0%Ovarian cyst
0%Diabetes mellitus inadequate control
0%Bladder transitional cell carcinoma
0%Arthralgia
0%Asthma
0%Back pain
0%Ruptured cerebral aneurysm
0%Alcohol abuse
0%Epilepsy
0%Musculoskeletal chest pain
0%Prostate cancer
0%Depression suicidal
0%Suicidal ideation
0%Ovarian haemorrhage
0%Hypertension
0%Diabetic foot
0%Hospitalisation
0%Gastritis
0%Ileus
0%Vertigo
0%Thrombocytopenia
0%Laryngitis
0%Contusion
0%Acute tonsillitis
0%Angina pectoris
0%Chest pain
0%Death
0%Lower respiratory tract infection
0%Lobar pneumonia
0%Costochondritis
0%Intervertebral disc protrusion
0%Intercostal neuralgia
0%Rib fracture
0%Breast cancer
0%Delirium tremens
0%Presyncope
0%Calculus ureteric
0%Intentional self-injury
0%Peripheral arterial occlusive disease
0%Migraine
0%Aortic aneurysm rupture
0%Hypertensive crisis
0%Pneumothorax
This histogram enumerates side effects from a completed 2013 Phase 4 trial (NCT01370356) in the Varenicline ARM group. Side effects include: Nausea with 28%, Nasopharyngitis with 13%, Insomnia with 11%, Abnormal dreams with 11%, Headache with 8%.

Trial Design

2 Treatment Groups

Varenicline + Self-Change Pamphlet
1 of 2
Placebo + Self-Change Pamphlet
1 of 2
Experimental Treatment
Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: Varenicline + Self-Change Pamphlet · Has Placebo Group · Phase 2

Varenicline + Self-Change Pamphlet
Drug
Experimental Group · 1 Intervention: Varenicline Tartrate · Intervention Types: Drug
Placebo + Self-Change Pamphlet
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varenicline Tartrate
2008
Completed Phase 4
~2840

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 12
Closest Location: Medical University of South Carolina · Charleston, SC
Photo of medical university of south carolina  1Photo of medical university of south carolina  2Photo of medical university of south carolina  3
1993First Recorded Clinical Trial
14 TrialsResearching Smoking, Cessation
1223 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing to set a quit date and maintain e-cigarette abstinence.
You have access to a smartphone or have regular (daily) access/use of email.
You live in South Carolina or Connecticut.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.