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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01061528
Other study ID # PHI0906-002
Secondary ID R01DA017332
Status Completed
Phase N/A
First received
Last updated
Start date September 2009
Est. completion date October 2013

Study information

Verified date September 2018
Source Butler Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of this study is to evaluate the efficacy of a new type of exposure- and acceptance-based smoking cessation treatment vs. standard behavioral smoking cessation treatment, in conjunction with the use of the transdermal nicotine patch. In both treatments, participants will receive one 60-minute individual session, seven 2-hour group sessions and two individual brief telephone contacts over an eight-week period. Both treatments include 8 weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue after the treatment sessions have ended. Participants will provide follow-up data with regard to their smoking status through a one-year follow-up period.


Description:

1. 18-65 years of age,

2. a regular smoker for at least one year,

3. currently smoking 10 or more cigarettes per day,

4. report motivation to quit smoking in the next month.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date October 2013
Est. primary completion date August 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 18-65 years old

- regular smoker for at least one year

- currently smoking 10 or more cigarettes per day

Exclusion Criteria:

- Current Axis I disorder

- Psychoactive substance abuse or dependence (excluding nicotine dependence) within past year

- Current suicidal risk

- Pregnancy or breast feeding

- Use of nicotine replacement products or bupropion

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Transdermal Nicotine
Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment.

Locations

Country Name City State
United States Butler Hospital Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
Butler Hospital National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Biochemically Verified Smoking Abstinence Carbon monoxide of expired air
Salivary cotinine level of saliva
Six months
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