NCT02845440 is a NA clinical trial of Academic Detailing in Cigarette Smoking, sponsored by Massachusetts General Hospital.

Who is sponsoring NCT02845440?

NCT02845440 is sponsored by Massachusetts General Hospital.

What drugs are being tested in NCT02845440?

Interventions in NCT02845440: Academic Detailing, Community Health Worker, Treatment as Usual (TAU).

What condition does NCT02845440 study?

NCT02845440 studies Cigarette Smoking, Schizophrenia, Bipolar Disorder, Depressive Disorder, Major, Smoking Cessation.

Is NCT02845440 still recruiting?

NCT02845440 is currently completed. Last updated 19 April 2022.

Are results published for NCT02845440?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-04-19 · How we verify

NCT02845440

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Integrated Smoking Cessation Treatment for Smokers With Serious Mental Illness

Completed NA Results posted Last updated 19 April 2022

What this trial tests

NA trial testing Academic Detailing in Cigarette Smoking in 1,165 participants. Completed in 12 January 2021.

Timeline

14 July 2016

Primary endpoint
2 February 2020

12 January 2021

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	1,165
Start date	14 July 2016
Primary completion	2 February 2020
Estimated completion	12 January 2021
Sites	1 location across United States

Drugs / interventions tested

Academic Detailing
Community Health Worker
Treatment as Usual (TAU) — full drug profile →

Conditions studied

Cigarette Smoking — all drugs for Cigarette Smoking →
Schizophrenia — all drugs for Schizophrenia →
Bipolar Disorder — all drugs for Bipolar Disorder →
Depressive Disorder, Major — all drugs for Depressive Disorder, Major →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with Cigarette Smoking or Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohort 1 Primary · Assessment at end of year 2 of intervention

Three pairwise comparisons between usual care (TAU), AD+CHW, and AD for number of participants who are abstinent (defined as 7-day point prevalence tobacco abstinence confirmed with an expired CO of 5 ppm or less) at the intervention year 2 assessment. The investigators hypothesize that (1) those who receive AD+CHW will demonstrate higher rates of tobacco abstinence than those who receive TAU, (2) those who receive AD will demonstrate higher rates of tobacco abstinence than those who received TAU, and (3) those who receive AD+CHW will demonstrate higher rates of tobacco abstinence than those w

Group	Value	95% CI
Treatment as Usual (TAU) Cohort 1	13
AD + CHW - Cohort 1	32
AD - Cohort 1	19

Number of Participants Who Use of Any First Line, Evidence-based TUD Medication at the Intervention Year 1 or 2 Assessment in Cohort 1 Secondary · Any use over assessments for years 1 or 2 of intervention

Two comparisons, usual care (TAU) versus AD+CHW and TAU versus AD, for use of any first line, evidence-based TUD medication during assessments for years 1 and 2 of the intervention. The investigators hypothesize that (1) those who receive AD+CHW will demonstrate higher rates of medication use than those who received TAU, and (2) those who receive AD will demonstrate higher rates of medication use than those who received TAU.

Group	Value	95% CI
Treatment as Usual (TAU) Cohort 1	112
AD + CHW - Cohort 1	121
AD - Cohort 1	83
Treatment as Usual (TAU) Cohort 1	152
AD + CHW - Cohort 1	138
AD - Cohort 1	181

Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessment in Cohort 1 Secondary · Any use over assessments for years 1 or 2 of intervention

Two comparisons, usual care (TAU) versus AD+CHW and TAU versus AD, for use of varenicline during assessments for years 1 and 2 of the intervention. The investigators hypothesize that (1) those who receive AD+CHW will demonstrate higher rates of varenicline use than those who received TAU, and (2) those who receive AD will demonstrate higher rates of varenicline use than those who received TAU.

Group	Value	95% CI
Treatment as Usual (TAU) Cohort 1	34
AD + CHW - Cohort 1	72
AD - Cohort 1	30
Treatment as Usual (TAU) Cohort 1	230
AD + CHW - Cohort 1	187
AD - Cohort 1	234

Effect of Use of Any TUD Medication on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 Secondary · Assessment at end of year 2 of intervention

Effect of use of any first line, evidence-based TUD medication during assessments for years 1 and 2 of the intervention on number of participants who are abstinent (defined as 7-day point prevalence tobacco abstinence confirmed with an expired CO of 5 ppm or less) at the intervention year 2 assessment. The investigators hypothesize that those who used any medication will exhibit higher rates of tobacco abstinence than those who did not use any medications. The indirect effect of AD+CHW and AD interventions on abstinence rates with any TUD medication use as a mediator will be also be assessed.

Group	Value	95% CI
Treatment as Usual (TAU) - Cohort 1	5
AD + CHW - Cohort 1	24
AD - Cohort 1	7
Treatment as Usual (TAU) - Cohort 1	8
AD + CHW - Cohort 1	8
AD - Cohort 1	12
Treatment as Usual (TAU) - Cohort 1	107
AD + CHW - Cohort 1	97
AD - Cohort 1	76
Treatment as Usual (TAU) - Cohort 1	144
AD + CHW - Cohort 1	130
AD - Cohort 1	169

Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 Secondary · Assessment at end of year 2 of intervention

Effect of use of varenicline during assessments for years 1 and 2 of the intervention on number of participants who are abstinent (defined as 7-day point prevalence tobacco abstinence confirmed with an expired CO of 5 ppm or less) at the intervention year 2 assessment. The investigators hypothesize that those who used varenicline will exhibit higher rates of tobacco abstinence than those who did not use any varenicline. The indirect effect of AD+CHW and AD interventions on abstinence rates with any TUD medication use as a mediator will be also be assessed.

Group	Value	95% CI
Treatment as Usual (TAU) - Cohort 1	1
AD + CHW - Cohort 1	17
AD - Cohort 1	4
Treatment as Usual (TAU) - Cohort 1	12
AD + CHW - Cohort 1	15
AD - Cohort 1	15
Treatment as Usual (TAU) - Cohort 1	33
AD + CHW - Cohort 1	55
AD - Cohort 1	26
Treatment as Usual (TAU) - Cohort 1	218
AD + CHW - Cohort 1	172
AD - Cohort 1	219

Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohorts 1 and 2 Secondary · Assessment at end of year 2 of intervention

Comparisons between (1) CHW (pooled over AD+CHW and CHW) and (2) AD (pooled over AD+CHW and AD) compared to usual care (TAU) on number of participants who are abstinent (defined as 7-day point prevalence tobacco abstinence confirmed with an expired CO of 5 ppm or less) at the intervention year 2 assessment. The investigators hypothesize that (1) those who receive CHW support will demonstrate higher rates of tobacco abstinence than those who receive TAU, and (2) those with AD exposure will demonstrate higher rates of tobacco abstinence than those who received TAU. To make use of all the data, h

Group	Value	95% CI
Treatment as Usual (TAU) Cohort 1	13
AD + CHW - Cohort 1	32
AD - Cohort 1	19
CHW - Cohort 2	11
Treatment as Usual (TAU) Cohort 2	8

Number of Participants Who Use of Any First Line, Evidence-based TUD Medication at the Intervention Year 1 or 2 Assessment in Cohorts 1 and 2 Secondary · Any use over assessments for years 1 or 2 of intervention

Effects of CHW (pooled over AD+CHW and CHW) and AD (pooled over AD+CHW and AD) compared to usual care (TAU) on number of participants who use of any first line, evidence-based TUD medication during assessments for years 1 and 2 of the intervention. The investigators hypothesize that (1) those who receive CHW support will demonstrate higher rates of medication use than those who receive TAU, and (2) those with AD exposure will demonstrate higher rates of medication use than those who received TAU. To make use of all the data, hypotheses will be assessed in Cohorts 1 and 2 via analysis of a fact

Group	Value	95% CI
Treatment as Usual (TAU) Cohort 1	112
AD + CHW - Cohort 1	121
AD - Cohort 1	83
CHW - Cohort 2	30
Treatment as Usual (TAU) Cohort 2	24
Treatment as Usual (TAU) Cohort 1	152
AD + CHW - Cohort 1	138
AD - Cohort 1	181
CHW - Cohort 2	27
Treatment as Usual (TAU) Cohort 2	33

Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessments in Cohorts 1 and 2 Secondary · Any use over assessments for years 1 or 2 of intervention

Effects of CHW (pooled over AD+CHW and CHW) and AD (pooled over AD+CHW and AD) compared to usual care (TAU) on number of participants who use varenicline during assessments for years 1 and 2 of the intervention. The investigators hypothesize that (1) those who receive CHW support will demonstrate higher rates of varenicline use than those who receive TAU, and (2) those with AD exposure will demonstrate higher rates of varenicline use than those who received TAU. To make use of all the data, hypotheses will be assessed in Cohorts 1 and 2 via analysis of a factorial design.

Group	Value	95% CI
Treatment as Usual (TAU) Cohort 1	34
AD + CHW - Cohort 1	72
AD - Cohort 1	30
CHW - Cohort 2	15
Treatment as Usual (TAU) Cohort 2	6
Treatment as Usual (TAU) Cohort 1	230
AD + CHW - Cohort 1	187
AD - Cohort 1	234
CHW - Cohort 2	42
Treatment as Usual (TAU) Cohort 2	51

Effect of Use of Any TUD Medication on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohorts 1 and 2 Secondary · Assessment at end of year 2 of intervention

Effect of use of any first line, evidence-based TUD medication during assessments for years 1 and 2 of the intervention on number of participants who are abstinent (defined as 7-day point prevalence tobacco abstinence confirmed with an expired CO of 5 ppm or less) at the intervention year 2 assessment. The investigators hypothesize that those who used any medication will exhibit higher rates of tobacco abstinence than those who did not use any medications. To make use of all the data, the hypothesis will be assessed in Cohorts 1 and 2 via analysis of a factorial design. The indirect effect of

Group	Value	95% CI
Treatment as Usual (TAU) - Cohort 1	5
AD + CHW - Cohort 1	24
AD - Cohort 1	7
CHW - Cohort 2	7
Treatment as Usual (TAU) - Cohort 2	2
Treatment as Usual (TAU) - Cohort 1	8
AD + CHW - Cohort 1	8
AD - Cohort 1	12
CHW - Cohort 2	4
Treatment as Usual (TAU) - Cohort 2	6
Treatment as Usual (TAU) - Cohort 1	107
AD + CHW - Cohort 1	100
AD - Cohort 1	78
CHW - Cohort 2	23
Treatment as Usual (TAU) - Cohort 2	22
Treatment as Usual (TAU) - Cohort 1	144
AD + CHW - Cohort 1	127
AD - Cohort 1	167
CHW - Cohort 2	23
Treatment as Usual (TAU) - Cohort 2	27

Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohorts 1 and 2 Secondary · Assessment at end of year 2 of intervention

Effect of use of varenicline during assessments for years 1 and 2 of the intervention on number of participants who are abstinent (defined as 7-day point prevalence tobacco abstinence confirmed with an expired CO of 5 ppm or less) at the intervention year 2 assessment. The investigators hypothesize that those who used varenicline will exhibit higher rates of tobacco abstinence than those who did not use any varenicline. To make use of all the data, the hypothesis will be assessed in Cohorts 1 and 2 via analysis of a factorial design. The indirect effect of CHW and AD interventions on abstinenc

Group	Value	95% CI
Treatment as Usual (TAU) - Cohort 1	1
AD + CHW - Cohort 1	17
AD - Cohort 1	4
CHW - Cohort 2	5
Treatment as Usual (TAU) - Cohort 2	0
Treatment as Usual (TAU) - Cohort 1	12
AD + CHW - Cohort 1	15
AD - Cohort 1	15
CHW - Cohort 2	6
Treatment as Usual (TAU) - Cohort 2	8
Treatment as Usual (TAU) - Cohort 1	33
AD + CHW - Cohort 1	55
AD - Cohort 1	26
CHW - Cohort 2	10
Treatment as Usual (TAU) - Cohort 2	6
Treatment as Usual (TAU) - Cohort 1	218
AD + CHW - Cohort 1	172
AD - Cohort 1	219
CHW - Cohort 2	36
Treatment as Usual (TAU) - Cohort 2	43

Health-related Quality of Life Single-item Assessment at the Intervention Year 2 Assessment in Cohort 1 Secondary · Assessment at end of year 2 of intervention

Three pairwise comparisons between usual care (TAU), AD+CHW, and AD for health-related quality of life at the intervention year 2 assessment as assessed with the single-item self-reported Overall Health (SF-1) scale (measured on a 5-point scale from 1 = 'poor' to 5 = 'excellent'). The investigators hypothesize that (1) those who receive AD+CHW will demonstrate improved quality of life compared than those who receive TAU, (2) those who receive AD will demonstrate improved quality of life compared those who received TAU, and (3) those who receive AD+CHW will demonstrate improved quality of life

Group	Value	95% CI
Treatment as Usual (TAU) - Cohort 1	3.02	± 0.96
AD + CHW - Cohort 1	3.13	± 1.06
AD - Cohort 1	3.08	± 0.99

Health-related Quality of Life Single-item Assessment at the Intervention Year 2 Assessment in Cohorts 1 and 2 Secondary · Assessment at end of year 2 of intervention

Comparisons between (1) CHW (pooled over AD+CHW and CHW) and (2) AD (pooled over AD+CHW and AD) compared to usual care (TAU) on health-related quality of life at the intervention year 2 assessment as assessed with the single-item self-reported Overall Health (SF-1) scale (measured on a 5-point scale from 1 = 'poor' to 5 = 'excellent'). The investigators hypothesize that (1) those who receive CHW support will demonstrate improved quality of life compared to those who receive TAU, and (2) those with AD exposure will demonstrate improved quality of life compared to those who received TAU. To make

Group	Value	95% CI
Treatment as Usual (TAU) - Cohort 1	3.02	± 0.96
AD + CHW - Cohort 1	3.13	± 1.06
AD - Cohort 1	3.08	± 0.99
CHW - Cohort 2	3.11	± 1.06
Treatment as Usual (TAU) - Cohort 2	3.35	± 0.90

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 years. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment as Usual (TAU) - Cohort 1

Serious: 90/333 (27%)

Deaths: 14/333

AD + CHW - Cohort 1

Serious: 119/336 (35%)

Deaths: 18/336

AD - Cohort 1

Serious: 108/341 (32%)

Deaths: 16/341

CHW - Cohort 2

Serious: 26/78 (33%)

Deaths: 3/78

Treatment as Usual (TAU) - Cohort 2

Serious: 24/77 (31%)

Deaths: 0/77

Serious adverse events (2 terms)

Reaction	System	Treatment as Usual (TAU) -…	AD + CHW - Cohort 1	AD - Cohort 1	CHW - Cohort 2	Treatment as Usual (TAU) -…
Psychiatric hospitalization	Psychiatric disorders	—	—	—	—	—
Medical hospitalization	General disorders	—	—	—	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Treatment as Usual (TAU) -…	AD + CHW - Cohort 1	AD - Cohort 1	CHW - Cohort 2	Treatment as Usual (TAU) -…
Incarceration	Social circumstances	—	—	—	—	—

Most-reported serious reactions: Psychiatric hospitalization, Medical hospitalization.

Data from ClinicalTrials.gov NCT02845440 adverse events section.

Sponsor's own description

The overall aim of this study is to test the effect of academic detailing (i.e. provider-level educational intervention focused on evidence-based smoking cessation treatment for those with psychiatric illness) and community health worker (CHW) support on the provision and utilization of standard of care smoking cessation treatment to those with serious mental illness (SMI) and smoking cessation rates for adults with SMI who smoke.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Implementation of Community Health Worker Support for Tobacco Cessation: A Mixed-Methods Study.
Foo CYS, Potter K, Nielsen L, Rohila A, et al · · 2025 · cited 6× · PMID 39118574 · DOI 10.1176/appi.ps.20240044

Verify or expand the search:

Other trials of Academic Detailing

Trials testing the same drug.

NCT05534412 — A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence · NA · active not recruiting
NCT03445559 — A Multi-modal, Physician-centered Intervention to Improve Guideline-concordant Prostate Cancer Imaging · NA · active not recruiting
NCT02765412 — PrOVE QUERI Project #1 · completed

Other recruiting trials for Cigarette Smoking

Currently open trials in the same condition.

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NCT07014124 — Smoking Cessation for Fathers of Sick Children · NA · recruiting
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NCT06609083 — Effect of Cannabis on Cigarette Use Behavior · Phase 1 · recruiting
NCT05587361 — Beta-Adrenergic Modulation of Drug Cue Reactivity · Phase 4 · recruiting

Other Massachusetts General Hospital trials

Trials by the same sponsor.

NCT03585946 — Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis · withdrawn
NCT07214831 — A Feasibility and Acceptability Study of a Large Language Model-based Chatbot for Brief Alcohol Intervention Among Emerg · NA · not yet recruiting
NCT06686901 — A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior · NA · not yet recruiting
NCT05854212 — Behavioral Economics to Implement Nutrition Ranking in Food Pantries · NA · not yet recruiting
NCT07323446 — The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation · EARLY_PHASE1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02845440 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
Last refreshed: 19 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02845440.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing