Directly Observed Therapy for Tobacco Use Disorder

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Tobacco Use Disorder+1 MoreDirectly Observed Therapy - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test two interventions: directly observed medication therapy, and long-term therapy with varenicline among 450 smokers with opioid use disorder recruited from community-based, outpatient opioid treatment programs.

Eligible Conditions
  • Tobacco Use Disorder
  • Opioid Use Disorder

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: week 52

24 weeks
Cigarettes smoked per day
Initial abstinence
Nicotine dependence
Quality of life
Time to lapse
Time to relapse
week 52
Durability of tobacco abstinence

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

4 Treatment Groups

Self Administered Therapy
1 of 4
Short-Term Varenicline
1 of 4
Long-Term Varenicline
1 of 4
Directly Observed Therapy
1 of 4

Active Control

Experimental Treatment

450 Total Participants · 4 Treatment Groups

Primary Treatment: Directly Observed Therapy · No Placebo Group · Phase 4

Long-Term Varenicline
Drug
Experimental Group · 1 Intervention: Long-Term Varenicline · Intervention Types: Drug
Directly Observed Therapy
Behavioral
Experimental Group · 1 Intervention: Directly Observed Therapy · Intervention Types: Behavioral
Self Administered Therapy
Behavioral
ActiveComparator Group · 1 Intervention: Self Administered Therapy · Intervention Types: Behavioral
Short-Term Varenicline
Drug
ActiveComparator Group · 1 Intervention: Short-Term Varenicline · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Directly Observed Therapy
2019
N/A
~540

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 52

Who is running the clinical trial?

PfizerIndustry Sponsor
4,308 Previous Clinical Trials
7,110,387 Total Patients Enrolled
23 Trials studying Tobacco Use Disorder
3,462 Patients Enrolled for Tobacco Use Disorder
National Institute on Drug Abuse (NIDA)NIH
2,248 Previous Clinical Trials
2,028,637 Total Patients Enrolled
255 Trials studying Tobacco Use Disorder
47,270 Patients Enrolled for Tobacco Use Disorder
Albert Einstein College of MedicineLead Sponsor
265 Previous Clinical Trials
1,838,816 Total Patients Enrolled
3 Trials studying Tobacco Use Disorder
245 Patients Enrolled for Tobacco Use Disorder
National Institutes of Health (NIH)NIH
2,442 Previous Clinical Trials
24,577,828 Total Patients Enrolled
43 Trials studying Tobacco Use Disorder
25,966 Patients Enrolled for Tobacco Use Disorder
Shadi Nahvi, MD, MSPrincipal InvestigatorAlbert Einstein College of Medicine

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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