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Nicotinic Acetylcholine Receptor Partial Agonist

Varenicline for Nicotine Addiction

Phase 4
Waitlist Available
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of study, an average of 2 years
Awards & highlights

Study Summary

This trial is testing whether a lower dose and slower titration schedule of varenicline, combined with behavioral treatment, is feasible for smokers with bipolar disorder, schizophrenia or schizoaffective disorder who are motivated to quit.

Eligible Conditions
  • Nicotine Addiction
  • Bipolar Disorder
  • Schizoaffective Disorder
  • Schizophrenia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of study, an average of 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of study, an average of 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of Combining ACT With 2 Different Varenicline-assisted Quitting Strategies
Secondary outcome measures
Explore whether nicotine metabolism influences medication tolerability
Other outcome measures
Nicotine Metabolite Ratio (NMR) Exploratory Aim

Side effects data

From 2022 Phase 4 trial • 39 Patients • NCT04011280
50%
Dysgeusia
50%
Anxiety
36%
Sleep Disturbances
29%
Nausea
21%
Depression
21%
Agitation
21%
Headache
14%
Allergies
14%
Heartburn
14%
Cold
14%
Back Pain
7%
Cellulitis
7%
Sinusitis
7%
Stomach Pain
7%
Panic
7%
Angina
7%
Aggression
7%
Palpitations
7%
Rash
7%
Confusion
7%
Dizziness
7%
Fatigue
7%
Leg Spasms
7%
Increased Blood Pressure
7%
Malaise
7%
Weight Gain
7%
Gum Disease
7%
Pharyngitis
7%
Leg Cramps
7%
Muscle Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low Dose Varenicline
Standard Dose Varenicline

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Low Dose VareniclineExperimental Treatment1 Intervention
0.5 mg twice daily with 0.5 mg daily titration over one full week
Group II: Standard Dose VareniclineActive Control1 Intervention
1.0 mg twice daily with standard titration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varenicline
FDA approved

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,122 Previous Clinical Trials
1,521,005 Total Patients Enrolled
Veterans Medical Research FoundationOTHER
43 Previous Clinical Trials
4,895 Total Patients Enrolled
University of CaliforniaOTHER
42 Previous Clinical Trials
417,309 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Varenicline for medical use?

"There is evidence showing Varenicline's safety from Phase 4 trials, thus it was given a rating of 3."

Answered by AI

Are people aged 40 and younger qualified to participate in the investigation?

"As stipulated in the requirements for participation, individuals must be between 18 and 70 years old to qualify."

Answered by AI

Are there opportunities for participants to join this medical investigation?

"Affirmative. Clinicaltrials.gov attests that this trial, initially advertised on July 15th 2019 and revised October 4th 2021, is actively enrolling 60 patients from one medical site."

Answered by AI

How many participants have been inducted into this medical research endeavor?

"Affirmative. The clinicaltrials.gov website attests that this experiment is recruiting participants, having been initially posted on July 15th 2019 and recently revised on October 4th 2021. 60 patients need to be found from a single facility for the trial's success."

Answered by AI

Are there any recorded accounts of studies done on Varenicline?

"Currently, 26 clinical trials have been initiated to explore the efficacy of Varenicline. Of these active studies, 4 are in their final phase. Most of the research is conducted in Charleston, South carolina but there are 69 other medical centres participating in this investigation."

Answered by AI

Do I have the necessary qualifications to join this investigation?

"This scientific inquiry seeks 60 volunteers with manic disorder aged between 18 and 70. Applicants must be able to procure the services of a mental health provider, demonstrate an age range that falls within 18-70 years old, and possess a desire to quit smoking."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness
Robert Anthenelli, MD 2019. "Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04011280.
~7 spots leftby Apr 2025
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