Extended Treatment for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Extended Treatment for Smoking Cessation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01330043
• Other study ID #: SU-09272010-6949
• Secondary ID: R01DA017441
• Status: Active, not recruiting
• Phase: N/A
• First received: October 7, 2010
• Last updated: May 12, 2014
• Start date: March 2010
• Est. completion date: March 2015

Study information

• Verified date: May 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Adult smokers (21-65) and adolescent smokers (18 - 21) years of age residing in Alameda and Santa Clara counties will serve as the target population for this study. A total of 400 smokers meeting eligibility criteria will be randomized. Treatment will include both open label and extended treatment phases. Randomization. Participants will be randomized to extended therapy or control conditions at baseline (prior to open label treatment) and the analysis will be intention-to-treat (ITT) to avoid the threat of selection bias. Primary hypothesis. Smokers randomized to receive CBT during extended treatment will have a higher prolonged abstinence rate (PA) at 52 week and 104 week follow-up than participants in the Supportive therapy Control treatment.

Description:

During open label treatment, all receive CBT and zyban and nicotine patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and nicotine replacement therapy (NRT) through week 26. Medication will not be available after week 26. All will receive CBT through week 26.

Other known NCT identifiers

• NCT01067612

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age at least 18 years at the beginning of the study Smoking at least 10 cigarettes a day (1/2 pack)

Exclusion Criteria:

1. Currently pregnant

2. Currently breastfeeding

3. Currently diagnosed with a seizure disorder, major depression, liver disease, kidney disease, congestive heart failure or diabetes mellitus

4. History of a seizure, seizure disorder, significant head trauma or central nervous system tumor

5. Family history of seizures

6. Currently using intravenous drugs

7. Currently using any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.) on a daily basis

8. Currently using any over-the-counter stimulants and anorectics (diet pills)

9. Currently on bupropion (Wellbutrin, Wellbutrin SR) or other antidepressants, monoamine oxidase inhibitors, antipsychotics, benzodiazepines, theophylline, systemic steroids or levodopa

10. Currently on NRT or bupropion (Zyban)

11. Current or past diagnosis of anorexia nervosa or bulimia nervosa

12. Previous allergic response to bupropion or NRT

Study Design

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• cognitive behavior therapy (CBT)
During open label treatment, all receive CBT and zyban and nicotine patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. Medication will not be available after week 26. All will receive CBT through week 26.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	smoking abstinence		52 and 104 week follow-up	No
Secondary	smoking relapse		52 and 104 week follow-up	No