Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217984
Status:
COMPLETED
Last Update Posted:
2017-11-01
First Post:
2005-09-16
Brief Title:
Intensive Intervention for Smokers - 6
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Intensive Intervention for Smokers in Alcohol Treatment
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to determine the efficacy and cost-effectiveness of an intensive smoking cessation intervention that utilizes extended cognitive-behavioral therapy and combination nicotine replacement CNR in a randomized controlled trial The intensive intervention was compared to usual care involving referral to a free-standing smoking cessation program that provides brief counseling and CNR We recruited 162 smokers ages 18 to 75 who are enrolled in the Drug and Alcohol Treatment DAT programs at the San Francisco VA Medical Center SFVAMC and Santa Rosa VA Community-based Outpatient Clinic CBOC To be eligible participants had to be abstinent from alcohol for at least one week but not more than 30 days We compared outcomes for the two study arms by assessing biochemically-validated point-prevalence smoking status at 3 6 9 and 12 months post-baseline and continuous abstinence over the 12-month follow-up Expired-air carbon monoxide CO was used to biochemically verify 7-day point prevalence abstinence We also conducted an economic analysis to determine the cost-effectiveness of the intensive intervention compared with usual care We also examined cross-relapse patterns during the follow-up period assessing changes in mood states and use of tobacco alcohol and other drugs at 3 6 9 and 12 months
Detailed Description:
Introduction The purpose of this study was to investigate the efficacy of an intensive tobacco cessation intervention for alcohol-dependent smokers in early recovery
Methods A total of 162 alcohol-dependent smokers were randomized to either intensive intervention for smoking cessation or usual care The intensive intervention consisted of 16 sessions of individual cognitive behavior therapy CBT and combination nicotine replacement therapy that lasted 26 weeks Usual care involved referral to a free-standing smoking cessation program that provided smoking cessation counseling of varying duration and guideline-concordant medications The primary cessation outcome was verified 7-day point prevalence abstinence PPA at 12 26 38 and 52 weeks
Results At 12 and 26 weeks the verified 7-day point-prevalence quit rate was significantly higher for the intensive intervention group than for the usual care group both p 03 However the quit rates for the two treatment groups were not significantly different at 38 or 52 weeks Verified 30-day alcohol abstinence rates were not significantly different for the two treatment groups at any of the follow-up assessments
Conclusions The intensive smoking cessation intervention yielded a higher short-term smoking quit rate without jeopardizing sobriety A chronic care model might facilitate maintenance of smoking cessation during the first year of alcohol treatment and perhaps for longer periods of time It is hoped that studies such as this will inform the development of more effective interventions for concurrent alcohol and tobacco use disorders
Methods A total of 162 alcohol-dependent smokers were randomized to either intensive intervention for smoking cessation or usual care The intensive intervention consisted of 16 sessions of individual cognitive behavior therapy CBT and combination nicotine replacement therapy that lasted 26 weeks Usual care involved referral to a free-standing smoking cessation program that provided smoking cessation counseling of varying duration and guideline-concordant medications The primary cessation outcome was verified 7-day point prevalence abstinence PPA at 12 26 38 and 52 weeks
Results At 12 and 26 weeks the verified 7-day point-prevalence quit rate was significantly higher for the intensive intervention group than for the usual care group both p 03 However the quit rates for the two treatment groups were not significantly different at 38 or 52 weeks Verified 30-day alcohol abstinence rates were not significantly different for the two treatment groups at any of the follow-up assessments
Conclusions The intensive smoking cessation intervention yielded a higher short-term smoking quit rate without jeopardizing sobriety A chronic care model might facilitate maintenance of smoking cessation during the first year of alcohol treatment and perhaps for longer periods of time It is hoped that studies such as this will inform the development of more effective interventions for concurrent alcohol and tobacco use disorders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50DA009253 | NIH | None | httpsreporternihgovquickSearchP50DA009253 |