Targeted Intervention for Bipolar Smokers

Bipolar Disorder Clinical Trial

Official title:

Targeted Intervention for Bipolar Smokers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01550029
• Other study ID #: 09-09-14-02
• Secondary ID: 1K23DA026517-01A
• Status: Active, not recruiting
• Phase: N/A
• First received: April 21, 2011
• Last updated: January 3, 2014
• Start date: July 2010
• Est. completion date: August 2014

Study information

• Verified date: January 2014
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

All participants will receive the nicotine patch, an FDA-approved smoking cessation medication, in an open-label fashion. In addition to the nicotine patch, participants will be randomized to receive one of the two types of counseling for smoking cessation. Participants will be in the research study for approximately 18 weeks. The total number of study visits is 15.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants who are motivated to quit smoking

• Male or female

• 18 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Nicotine Dependence

Intervention

Behavioral:
• Counseling/Healthy Lifestyle
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.
• Counseling/Managing Mood
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.

Locations

Country	Name	City	State
United States	The University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolonged Abstinence from Smoking	Confirmed prolonged abstinence from smoking during the last 4 weeks of the treatment period.	Last four weeks of treatment period	No
Secondary	Prevalence of Abstinence from Smoking	Prevalence abstinence will be assessed during the last 7 days of treatment period, 7 days prior to follow-up visit.	Last 7 days of treatment period	No