1. Effect of Depression on Smoking Cessation Outcomes Sonne SC 1, Nunes EV 2, Jiang H 2, Gan W 2, Tyson C 1, Reid MS 3 1 Medical University of South Carolina, 2 Columbia University/New York Psychiatric Institute, 3 New York University School of Medicine ABSTRACT: A great deal of literature has been published on the effect of both cigarette smoking and cessation on mood. Less information is available on the effect of mood on smoking cessation outcomes, particularly in a substance abusing population. The NIDA Clinical Trials Network recently completed a randomized, open label trial comparing the use of nicotine patches plus group counseling and treatment as usual (TAU) to TAU alone for substance-dependent outpatients interested in quitting smoking. We evaluated the effect of depression on smoking cessation outcomes. A total of 225 individuals were randomized in a 2:1 ratio to either Smoking Cessation (SC; n=153) or TAU (n=72). Approximately 31.1% of the sample (n=70) had baseline Beck Depression Inventory (BDI) scores > 20, and approximately half of the sample (n=110) reported a lifetime history of major depression (MDD). Individuals with a history of MDD reported an earlier age of onset for cigarette smoking (13.1 (3.7) vs. 14.3 (4.6) yrs; p=0.032), an earlier age of regular smoking (15.2 (3.7) vs. 16.7 yrs; p=0.010) as well as a higher baseline Fagerstrom score (6.6 (1.9) vs. 5.3 (2.0; p 20 smoked 26.3 (14.6) cigarettes/day vs. 21.3 (9.0) p=0.002) as well as started regular smoking at an earlier age (15.0 (3.8) vs. 16.5 (4.9); p=0.034). Although there was not a statistically significant effect of lifetime history of major depression on smoking abstinence rates (9.3% MDD, vs. 4.3% no MDD), there was a greater probability for smoking abstinence for those with lower baseline BDI scores (p=0.041). These data suggest that for individuals with substance dependence who are interested in quitting smoking, evaluation and treatment of depressive symptoms may play an important role in improving smoking cessation outcomes. INTRODUCTION METHODS RESULTS- BaselineRESULTS- Baseline (continued) RESULTS Outcome Although there is a great deal of data on the effect of smoking cessation on mood, there is less information on the effect of mood on smoking cessation outcomes. The Clinical Trials Network recently completed an 8-week, open-label trial comparing the use of nicotine patches plus group counseling and treatment as usual (TAU) to TAU alone in a group of substance dependant outpatients interested in quitting smoking. We conducted a secondary analysis to evaluate the effect of depression on smoking cessation outcomes. This study was an 8-week open-label trial comparing TAU plus nicotine patches and smoking cessation counseling (SC) to TAU alone; participants were randomized in a 2:1 ratio. SUBJECTS 225 men and women, 18 years of age or older Enrolled in a drug-free or opioid replacement treatment program for the last 30 days and scheduled to remain in treatment for 30 days after randomization Must meet DSM-IV criteria for drug or alcohol dependence in the last year; if on opioid replacement must be on stable dose Must smoke at least 10 cigarettes/day and have a CO>10ppm Could not be receiving any other smoking cessation interventions Could not be have a medical or psychiatric condition in immediate need of treatment or that would be negatively affected by study PERTINENT ASSESSMENTS Psychiatric/Medical History Beck Depression Inventory II DSM-IV Checklist Fagerstrom Test for Nicotine Dependence Substance Use Report Smoking Status/Exhaled Carbon Monoxide (CO) Smoker Belief Questionnaire Smoking History Survey Participants were seen twice a week for the first two weeks then weekly. Table 1. Describes the total sample of 225 participants. As can be seen, there were no statistically significant differences in demographics between treatment groups. Also in Table 3, alcohol was more often the primary substance of abuse for those with a BDI > 20 compared to those with a BDI<20 (p=0.015), and there was a trend (p=0.07 and; p=0.06, respectively) for a higher percentage of cocaine and amphetamine as primary for those with a BDI score <20. In order to evaluate the effect of depression on smoking cessation outcomes, the total sample was divided into those who reported ever being treated for depression (MDD) vs. those had not (no MDD); the total was also divided into those with a baseline BDI score 20. As can be seen in Table 2, those with a history of MDD were less likely to be employed at baseline (p=0.034), and there was a trend for the same group to be less educated (p=0.061) CONCLUSIONS Variable MDD (n=110) No MDD (n=115) Test StatBDI<20 (n=149) BDI>20 (n=70) Test Stat Age42.1 (9.3)42.3 (10.2)NS41.6 (9.3)43.8 (10.2)NS % Male46.457.4  2=2.74; p=0.098 52.351.4NS Education11.3 (2.3)11.8 (2.0)t=1.88; p=0.061 11.7 (2.1)11.3 (2.2)NS Race % Caucasian % African Am % Hispanic 42.7 23.6 31.8 34.2 29.0 36.0 NS37.8 26.4 34.5 37.1 28.6 32.9 NS % Employed38.250.4  2=4.5; p=0.034 44.341.4NS Table 1. Demographics by Treatment Group NS33%40% Employed NS42% 22% 30% 37% 28% 35% Race % Caucasian % African Am. % Hispanic NS11.9 (2.1)11.4 (2.3)Education (yrs) NS53%51% Male NS41.0 (8.6)41.6 (10.2)Mean Age Test Statistic TAU (n=72)SC (n=153) Characteristic Table 2. Demographics by Affective Group VariableMDD (n=110)No MDD (n=115)Test StatBDI<20 (n=149)BDI>20 (n=70)Test Stat Total BDI-II score19.6 (12)12.5 (9.5)t=-4.89 p<.0019.6 (5.7)29.4 (8.1)t=20.89 p<.001 Primary Substance of abuse (DSM-IV) Alcohol (%) Amphetamines (%) Cannabis (%) Cocaine (%) Opioids (%) Sedatives/BZDs (%) 10.91 3.64 10.0 21.91 50.91 3.64 4.35 5.22 6.96 16.52 63.48 3.48 NS  2=3.14; p=0.08 NS 4.03 6.71 22.82 57.72 2.01 14.29 0.00 12.86 11.43 55.71 5.71  2=5.96; p=0.015  2=3.50; p=0.06 NS  2=3.29; p=0.07 NS Table 3. Clinical Characteristics VariableMDD (n=110)No MDD (n=115)Test StatBDI<20 (n=149)BDI>20 (n=70)Test Stat Age 1 st Smoked13.1 (3.7)14.3 (4.6)t=2.15 p=0.03213.9 (4.4)13.1 (3.8)NS Age of regular smoking15.2 (3.7)16.7 (5.2)t=2.6 p=0.01016.5 (4.9)15.0 (3.8)t=-2.13 p=0.034 Avg. cigarettes per day24.4 (13)22.1 (10.5)NS21.3 (9.0)26.3 (14.6)t=3.15 p=0.002 % Use of non-cig tobacco25.522.6NS22.227.1NS # quit attempts4.7 (5.7)5.6 (15.9)NS4.6 (12.0)6.4 (12.6)NS Baseline Fagerstrom6.6 (1.9)5.3 (2.0)t=-4.93 p<0.0015.6 (2.1)6.6 (1.8)t=3.46 p<0.001 Table 4. Smoking Characteristics by Affective Group As can be seen in Table 4, those with a history of MDD had earlier age of smoking initiation as well as an earlier age of regular smoking. Individuals with a higher baseline BDI were found to smoke more cigarettes than those with a BDI 20 were found to have higher Fagerstrom scores for nicotine dependence. As can be seen in Table 3, opioids were the primary substance of abuse for the majority of participants. Most of the recruitment sites used in this trial were opioid replacement programs. When evaluating primary substance by affective group, there was a trend for there to be more primary opioid use in those without a history of MDD (p=0.08). During the treatment phase of the study, the smoking abstinent rates in the TAU group were almost 0, so only those randomized to SC were evaluated to determine if depression moderates the effect of smoking abstinence. There is no strong evidence that history of MDD moderated the effect of treatment on the smoking abstinence. There is no strong evidence that baseline BDI level when used as a dichotomous variable (i.e. BDI 20), moderated the effect of treatment on the smoking abstinence. However, when baseline BDI score was used as a continuous variable, there was a significant effect of baseline BDI on smoking abstinence in which lower BDI scores predicted greater smoking abstinence (p = 0.0408). The effect of the SC treatment in the smoking abstinence is greater for those with a low baseline BDI than for those with a high baseline BDI. Thus, in this trial the baseline BDI score moderated the treatment effect on smoking abstinence rates. These data suggest that for individuals with substance dependence who are interested in quitting smoking, evaluation and treatment of depressive symptoms may play an important role in improving smoking cessation outcomes. Sponsored by the NIDA Clinical Trials Network