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Alkaloid

cytisinicline for Electronic Cigarette Use (ORCA-V1 Trial)

Phase 2
Waitlist Available
Research Sponsored by Achieve Life Sciences
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 weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Awards & highlights

ORCA-V1 Trial Summary

This trial is testing if cytisinicline is safe when taken three times a day for 12 weeks.

Eligible Conditions
  • Electronic Cigarette Use
  • Vaping

ORCA-V1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants With Vaping Abstinence During Weeks 9 to 12
Secondary outcome measures
Changes From Baseline in Quantitative Cotinine Levels from Week 2 to Week 12
Number of Participants Who Achieve Vaping Abstinence at Any Time Between Week 2 and Week 12 (Seven-Day Point Prevalence Rates)
Proportion of Participants With Vaping Abstinence During Weeks 3 to 6
+2 more

ORCA-V1 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cytisinicline + Behavioral SupportExperimental Treatment2 Interventions
one cytisinicline tablet PO TID plus behavioral support for 12 weeks
Group II: Placebo + Behavioral SupportPlacebo Group2 Interventions
one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cytisinicline
2023
Completed Phase 2
~210
Behavioral support
2022
Completed Phase 4
~2290

Find a Location

Who is running the clinical trial?

Achieve Life SciencesLead Sponsor
34 Previous Clinical Trials
6,958 Total Patients Enrolled
Daniel Cain, Vice-President Clinical ResearchStudy DirectorAchieve Life Sciences, Inc.
1 Previous Clinical Trials
792 Total Patients Enrolled

Frequently Asked Questions

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

How many total individuals will be taking part in this experiment?

"To begin this trial, 150 eligible patients must enroll. Those who wish to participate can do so at Rochester Clinical Research, Inc or Costal Carolina Research Center."

Answered by AI

Does this research project still need volunteers?

"That is correct. The clinical trial is currently running and according to the information available on clinicaltrials.gov, was last updated on 9/15/2022. They are looking for 150 individuals to take part in the study at 4 different locations."

Answered by AI

Has cytisinicline been accepted by the Food and Drug Administration?

"While there is insufficient data to support efficacy, cytisinicline has shown some safety in Phase 2 trials and is thus given a score of 2."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Tennessee
What site did they apply to?
Alliance for Multispecialty Research, LLC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
A Study of Cytisinicline for Vaping Cessation in Adult Smokers
2022. "A Study of Cytisinicline for Vaping Cessation in Adult Smokers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05431387.
~58 spots leftby Apr 2025
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