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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
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 moreTrial 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
2014
Completed Phase 2
~3430
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,274 Previous Clinical Trials
14,840,503 Total Patients Enrolled
17 Trials studying Tobacco Use Disorder
4,334 Patients Enrolled for Tobacco Use Disorder
National Institute on Drug Abuse (NIDA)NIH
2,488 Previous Clinical Trials
2,622,637 Total Patients Enrolled
272 Trials studying Tobacco Use Disorder
49,010 Patients Enrolled for Tobacco Use Disorder
Elise Weerts, Ph.D.Principal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
55 Total Patients Enrolled
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