Tobacco Use Disorder Clinical Trial
Official title:
Intensive Intervention for Smokers in Alcohol Treatment
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT02432066 -
Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions
|
Phase 2 | |
Completed |
NCT03960138 -
Examining the Effects of Neural Stimulation on Inhibitory Control and Cigarette Smoking
|
N/A | |
Recruiting |
NCT05030272 -
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
|
N/A | |
Completed |
NCT04646668 -
Comparative Abuse Liability Among African American and White Smokers
|
N/A | |
Completed |
NCT02560324 -
Effect of Ramelteon on Smoking Abstinence
|
Phase 2 | |
Completed |
NCT02347605 -
Medicinal Nicotine for Preventing Cue Induced Craving
|
N/A | |
Completed |
NCT01625767 -
Tobacco Approach Avoidance Training for Adolescent Smokers-1
|
Phase 2 | |
Completed |
NCT01428310 -
Study to Evaluate the Safety and Efficacy of Dietary Supplement Anatabloc in Reducing Daily Smokers' Urge to Smoke
|
Phase 1 | |
Completed |
NCT01442753 -
Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth
|
N/A | |
Completed |
NCT01570595 -
Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV
|
Phase 1/Phase 2 | |
Terminated |
NCT01800500 -
Interest in Smokeless Tobacco Product as a Substitution for Cigarettes in Current Smokers
|
N/A | |
Active, not recruiting |
NCT01539525 -
Screening to Augment Referral to Treatment- Project START
|
Phase 2 | |
Completed |
NCT01337817 -
A Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen in Healthy Smokers
|
Phase 1 | |
Completed |
NCT00967005 -
N-Acetyl Cysteine Plus Behavioral Therapy for Nicotine Dependent Pathological Gamblers
|
Phase 2 | |
Active, not recruiting |
NCT00751660 -
Screening Methods in Finding Lung Cancer Early in Current or Former Smokers
|
N/A | |
Completed |
NCT00790569 -
Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
|
N/A | |
Completed |
NCT00664261 -
Clinical Effort Against Secondhand Smoke (CEASE) Program or Standard Care in Helping Parents Stop Smoking
|
N/A | |
Completed |
NCT01213524 -
Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia
|
Phase 2 | |
Completed |
NCT00158145 -
Assessing the Variability Over Time of Tobacco Carcinogen Biomarkers in Smokers - 2
|
Phase 2 | |
Completed |
NCT00218179 -
Assessing the Link Between Smoke Carcinogen Biomarkers and Lung Cancer Risk - 1
|
N/A |