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A Randomized Trial of Concurrent verses Delayed Smoking Intervention for Patients in Alcohol Dependence Treatment

Background: Smoking contributes to a high morbidity and mortality rate in the general populace as well as within patients that abuse alcohol. In fact, a strong correlation exists between alcohol and cigarette consumption. Since many patients who undergo clinical dependence treatment are young, smoking cessation could possibly prevent the long term, reversible effects of smoking in this patient population.

Objective: The objective of this study was to determine if smoking interventions administered concurrently with alcohol dependence treatment or delayed for six months after alcohol dependence treatment affected smoking and alcohol use.

Methods: This was a controlled, parallel, randomized, multicenter, non-blinded clinical trial. Four hundred and ninety-nine patients were enrolled in the study and randomly assigned to receive smoking cessation counseling concurrently with alcohol counseling, or smoking counseling delayed for 6 months after alcohol counseling began. Men and women between the ages of 21 and 75 were eligible for the study. Additional inclusion criteria included the following: diagnosed alcohol abuse or alcohol dependence via the DSM-IV, history of smoking more than five cigarettes/day for more than one year, and participation in the first week of alcohol treatment prior to study enrollment. Exclusion criteria was as follows: diagnosed dementia or schizophrenia, no interest to stop smoking, inability to obey protocol because of psychiatric or cognitive deficits, refusal to provide a contact or source for corroborating information, and inability to attend visits with the investigators. Patients received both behavioral and pharmacological interventions to promote smoking cessation. Behavioral interventions included an initial one hour face-to-face session followed with up to three more sessions either face-to-face or via telephone. Pharmacological interventions were based on the quantity of cigarettes per day the patient smoked and could include nicotine patches alone, or a combination of nicotine patches and nicotine gum. Patients could receive therapy for up to one year and were mailed reminder cards every three months to aid in compliance. Smoking cessation and alcohol use was the main outcome measured 18 months after enrollment. Primary tobacco outcomes involved the self-reported 7-day point prevalent smoking abstinence. The primary alcohol outcome focused on six-month duration of alcohol abstinence assessed by the Timeline Follow Back (TLFB) which measures drinking quantity and frequency. Secondary outcomes in smoking cessation included smoking cessation at 3, 6, and 12 months; the number of quit and relapse episodes; and participation in treatment. Abstinence from alcohol and tobacco was to be measured via breath testing with either the measurement of exhaled carbon monoxide or breath alcohol concentration. The power of the study was adequately set at 80% for all measures. An intent to treat and exclusion of subjects analysis was performed. The intent to treat analysis classified patients who did not respond or dropped out of the study as continuing smokers.

Results: It was discovered that when offered concurrently, 78.5% of patients opted for smoking cessation compared to only 64.5% of patients in the delayed group (95% CI, 1.35-2.99, p=0.005). In the intention to treat analysis, at three months 15.5% of patients in the concurrent, and 4.4% of patients in the delayed group were abstaining from cigarettes (p<0.0001). At six months 10.8% of patients in the concurrent, and 5.2% of patients in the delayed group were still abstaining from cigarettes (p<0.02). At 18 months there was no significant difference in prolonged rates of smoking abstinence in either group. In the exclusion of subjects analysis, similar data was observed in abstinence rates at three and six months. At 18 months there were significant decreases in the amount of cigarettes smoked per day in non-abstinent patients compared to baseline (p<0.0001) in both groups. Seventy-seven percent of patients in the concurrent group and 71% of patients in the delayed group opted to use pharmacological therapy. Alcohol abstinence results yielded a 30-day point prevalent alcohol abstinence that was lower in the concurrent treated group than the delayed treatment group (p<0.004). The concurrently treated groups time to first use of alcohol was significantly shorter when compared to the delayed treatment group (p<0.025).

Strengths: Funding for the study was provided by a federal agency and conducted by practitioners that had no stake in the outcomes which will decrease any amounts of bias that may be involved throughout the study. Two screenings were used to select patients to be enrolled in the study which may have helped to not disrupt data gathering. The study utilized national guidelines to perform the interventions in both pharmacological and behavioral aspects so that similar results could be expected in similar population throughout the United States. Proper statistical tests were used to interpret data.

Weaknesses: The study was only partially blinded (data interpreters were blinded only). The investigators stated they were going to use biochemical outcomes to assess abstinence rates in both smoking and alcohol, but later stated that they did not carry these tests out in the majority of patients. Compliance of using pharmacological agents was not measured which may influence abstinence rates. Self reported data could have been unreliable in the absence of confirmatory tests. The patients were located in different treatment locations (inpatient vs. outpatient), and the locations differed in total hours spent in sessions related to smoking and alcohol cessation activities.

Conclusions: The study was relatively weak with respect to using biological markers to assess abstinence in both alcohol and tobacco. Additionally, the reasons for patients lost to follow up were not mentioned and a significant amount of the patients who dropped out constituted the entire study sample. Finally, abstinence rates were worse at six months in the concurrent group than in the delayed group which may suggest that one should opt to deal with alcohol addiction instead of smoking cessation first.

Joseph AM, Willenbring ML, Nugent SM, Nelson DB. A randomized trial of concurrent versus delayed smoking intervention for patients in alcohol dependence treatment. J. Stud. Alcohol. 2004;65:681-91.

Kris Chiplinski
PharmD Candidate