NCT02424188

Brief Summary

This study will determine whether an 18-month practical tobacco smoking cessation program integrating weight management counseling and exercise will be superior to treatment as usual in achieving prolonged smoking abstinence in persons with serious mental illness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 7, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

June 25, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

3.7 years

First QC Date

April 18, 2015

Results QC Date

April 9, 2025

Last Update Submit

June 18, 2025

Conditions

Mental Illness

Keywords

weight managementphysical activityTobacco smokingSerious mental illness

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Smoking Abstinence

    7-day point prevalence, biochemically validated

    measured at 18 months

Secondary Outcomes (9)

  • Smoking Abstinence - 3 Months

    from 15 to 18 months

  • Smoking Abstinence

    measured at 6 and 12 months

  • 12 Months Continuous Smoking Abstinence

    measured from 6 months to 18 months

  • Weight

    Baseline, 6 and 18 months

  • Body Mass Index

    Baseline, 18 months

  • +4 more secondary outcomes

Study Arms (2)

TRIUMPH intervention

EXPERIMENTAL

Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support

Other: TRIIUMPH Intervention

Treatment as Usual

NO INTERVENTION

referral to quit line

Interventions

TRIIUMPH InterventionOTHER

Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support

TRIUMPH intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or recurrent major depression meeting criteria for serious mental illness
  • Fagerstrom Test for Nicotine Dependence of ≥3 and daily cigarette smoking for at least the past 6 months (on days that cigarettes were available)
  • On stable psychotropic medication for mental illness for at least 30 days (i.e., antipsychotic medication for those with schizophrenia spectrum illness, mood stabilizer for those with bipolar disorder)
  • Competent and willing to give informed consent
  • Completion of baseline data collection
  • Willing to participate in smoking cessation intervention that includes combination of evidence-based behavioral (group and individual sessions) and pharmacotherapeutic smoking cessation aids

You may not qualify if:

  • Serious cardiovascular event (e.g. myocardial infarction, stroke) within the past 6 months
  • Serious unstable medical condition that limits life expectancy
  • Pregnant, breastfeeding, or planning a pregnancy during study period.
  • Alcohol or illicit substance use disorder if not sober/abstinent for ≥ 30 days
  • Planning to leave mental health program or move out of geographic area within 18 months Review by treating psychiatrist required for those with inpatient psychiatric hospitalization within six months of enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

  • Daumit GL, Evins AE, Cather C, Dalcin AT, Dickerson FB, Miller ER 3rd, Appel LJ, Jerome GJ, McCann U, Ford DE, Charleston JB, Young DR, Gennusa JV 3rd, Goldsholl S, Cook C, Fink T, Wang NY. Effect of a Tobacco Cessation Intervention Incorporating Weight Management for Adults With Serious Mental Illness: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Sep 1;80(9):895-904. doi: 10.1001/jamapsychiatry.2023.1691.

    PMID: 37378972DERIVED

MeSH Terms

Conditions

Mental DisordersMotor ActivityTobacco Smoking

Condition Hierarchy (Ancestors)

BehaviorSmokingTobacco Use

Results Point of Contact

Title
Gail Daumit, MD, MHS
Organization
Johns Hopkins University School of Medicine
gdaumit@jhmi.edu
410-614-6460

Study Officials

  • Gail L Daumit, MD, MHS

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

  • A. Eden Evins, MD, MPH

    Massachussetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2015

First Posted

April 22, 2015

Study Start

July 7, 2016

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

June 25, 2025

Results First Posted

June 25, 2025

Record last verified: 2025-06

Locations

US(1)