NCT01550029

Brief Summary

The purpose of this research is to develop and test a new type of smoking cessation counseling for individuals with bipolar disorder.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

July 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2011

Completed
11 months until next milestone

First Posted

Study publicly available on registry

March 9, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

January 7, 2014

Status Verified

January 1, 2014

Enrollment Period

4.1 years

First QC Date

April 21, 2011

Last Update Submit

January 3, 2014

Conditions

Nicotine DependenceBipolar Disorder

Keywords

SmokingTobaccoNicotineBipolar

Outcome Measures

Primary Outcomes (1)

  • Prolonged Abstinence from Smoking

    Confirmed prolonged abstinence from smoking during the last 4 weeks of the treatment period.

    Last four weeks of treatment period

Secondary Outcomes (1)

  • Prevalence of Abstinence from Smoking

    Last 7 days of treatment period

Study Arms (2)

Counseling/Mood Management

EXPERIMENTAL

A trained counselor will meet with subjects for approximately 60 minutes each week during the 12-week treatment period to provide support for quitting and to help you develop knowledge and skills that can help you quit. Also, subjects will receive the National Cancer Institute's "Clearing the Air" guide to smoking cessation. Some specific areas of focus for this intervention are managing negative moods without smoking and overcoming other obstacles to quitting.

Behavioral: Counseling/Managing Mood

Counseling/Healthy Lifestyle

ACTIVE COMPARATOR

A trained counselor will meet with subjects for approximately 60 minutes each week during the 12-week treatment period to provide support for quitting smoking and to help develop knowledge and skills for quitting. Also, subjects will receive the National Cancer Institute's "Clearing the Air" guide to smoking cessation. Some specific areas of focus for this intervention are developing a better understanding of reasons for smoking and the consequences of tobacco use and identifying ways to establish a healthier lifestyle.

Behavioral: Counseling/Healthy Lifestyle

Interventions

Counseling/Healthy LifestyleBEHAVIORAL

A trained counselor will meet with subjects for approximately 60 minutes each week during the 12-week treatment period to provide support for quitting and to help develop knowledge and skills for quitting. Also, the National Cancer Institute's "Clearing the Air" guide to smoking cessation will be given to subjects. Some specific areas of focus for this intervention are developing a better understanding of reasons for smoking and the consequences of tobacco use and identifying ways for establishing a healthier lifestyle.

Also known as: Behavior therapy
Counseling/Healthy Lifestyle
Counseling/Managing MoodBEHAVIORAL

A trained counselor will meet with subjects for approximately 60 minutes each week during the 12-week treatment period to provide support for quitting smoking and to help develop knowledge and skills for quitting. Also, subjects will receive the National Cancer Institute's "Clearing the Air" guide to smoking cessation. Some specific areas of focus for this intervention are managing negative moods without smoking and overcoming other obstacles to quitting.

Also known as: Behavior Therapy
Counseling/Mood Management

Eligibility Criteria

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

You may qualify if:

  • Participants who are motivated to quit smoking
  • Male or female
  • years of age or older
  • Diagnosed with bipolar disorder according to DSM-IV criteria
  • Stable on medication with no significant changes in the last 3 months before enrollment.
  • Smoking 10 cigarettes/day for the past 90 days

You may not qualify if:

  • Healthy volunteers
  • Patients not meeting the criteria for the diagnosis of Bipolar Disorder according to DSM-IV criteria
  • Not being and being treated with medication for the bipolar disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Cincinnati

Cincinnati, Ohio, 452219, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderBipolar DisorderSmoking

Interventions

CounselingBehavior Therapy

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBipolar and Related DisordersMood DisordersBehavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPsychotherapy

Study Officials

  • Jaimee Heffner, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2011

First Posted

March 9, 2012

Study Start

July 1, 2010

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

January 7, 2014

Record last verified: 2014-01

Locations

US(1)