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Alpha-7 nAChR Antagonist

[F18]-ASEM + Contingency Management for Tobacco Use Disorder

Phase 1
Waitlist Available
Led By Elise Weerts, Ph.D.
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial will study if nicotine-dependent smokers show changes in the α7 nicotinic acetylcholine receptor (nAChR) when compared to controls, and if this influences measures of tobacco abstinence.

Eligible Conditions
  • Tobacco Use Disorder
  • Tobacco Smoking

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Craving/Urge to smoke as determined via the Questionnaire of Subjective Urges (QSU)
Distribution volume (VT) as determined by [18F]-ASEM PET scan
Total withdrawal score on the Minnesota Nicotine Withdrawal Scale (MNWS)
Secondary outcome measures
Attention as assessed by Connors continuous performance task
Negative mood as determined by the Positive and negative affect scale (PANAS)
Number of Cigarettes smoked per day
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: [F18]-ASEM + Contingency ManagementExperimental Treatment2 Interventions
PET radiopharmaceutical 3-(1,4-diazabicyclo[3.2.2]nonan-4-yl)-6 [18F]fluorodibenzo[b,d]thiophene 5,5-dioxide with incentive payments.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
[F18]-ASEM (3-(1,4-diazabicyclo[3.2.2]nonan-4-yl)-6-[18F]fluorodibenzo[b,d]thiophene 5,5-dioxide)
2019
Completed Phase 1
~20
Contingency Management
2003
Completed Phase 2
~3220

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,259 Previous Clinical Trials
14,820,638 Total Patients Enrolled
17 Trials studying Tobacco Use Disorder
4,334 Patients Enrolled for Tobacco Use Disorder
National Institute on Drug Abuse (NIDA)NIH
2,465 Previous Clinical Trials
2,618,618 Total Patients Enrolled
271 Trials studying Tobacco Use Disorder
49,052 Patients Enrolled for Tobacco Use Disorder
Elise Weerts, Ph.D.Principal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
55 Total Patients Enrolled

Frequently Asked Questions

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

Does this trial include participants over 35 years of age?

"This trial calls for participants aged between 21 and 50 years old."

Answered by AI

Who would be ideal candidates for this research experiment?

"This research endeavour requires 18 volunteers aged between 21 and 50 who have been reliant on tobacco for at least two years. As well, participants must meet the criterion of general healthiness."

Answered by AI

What are the main aims of this medical experiment?

"This clinical trial's primary evaluation, which will take place over two weeks is to assess the Distribution Volume (VT) using a [18F]-ASEM PET scan. Secondary objectives include tracking Number of Days of Smoking Abstinence through measuring Carbon Oxide and Cotinine levels in exhaled breath and urine respectively; Performance on the Paced Serial Addition Task (PASAT); as well as noting down the daily Cigarette Consumption for past ninety days via self-report journaling."

Answered by AI

Is this research still accepting participants?

"Affirmative. Documents available through clinicaltrials.gov show that this medical experiment, which was initially posted on December 16th 2019, is actively recruiting participants. The study aims to recruit 18 volunteers at one site."

Answered by AI

Has this procedure obtained federal authorization?

"With limited clinical evidence regarding efficacy and safety, this treatment was assigned a score of 1."

Answered by AI

What is the cap on participants enrolled in this experiment?

"Affirmative. Clinicaltrials.gov lists this trial as currently recruiting, having been first published on December 16th 2019 and recently updated on June 7th 2022. The research team is seeking 18 individuals from a single site to participate in the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Brain Imaging in Tobacco Smokers During a Quit Attempt
2019. "Brain Imaging in Tobacco Smokers During a Quit Attempt". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04055467.
~3 spots leftby Apr 2025
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