Table 1.
Baseline characteristics of the study population
| Varenicline (n=57) |
Placebo (n=55) |
|
|---|---|---|
| Sociodemographic characteristics | ||
| Age, mean (sd) | 48 (9) | 48 (8) |
| Male sex, n (%) | 26 (46) | 27 (49) |
| Race/ethnicity, n (%) | ||
| Hispanic | 32 (56) | 28 (51) |
| Black | 14 (25) | 17 (31) |
| Non-Hispanic White | 5 (9) | 5 (9) |
| Other | 6 (10) | 5 (9) |
| ≤ High school education, n (%) | 41 (72) | 46 (84) |
| Married or living with partner, n (%)† | 23 (40) | 31 (57) |
| Employed, n (%) | 15 (26) | 17 (31) |
| Lifetime history of incarceration, n (%) | 42 (74) | 31 (56) |
| Unstable housing, n (%)‡ | 21 (37) | 14 (25) |
| Tobacco Use Characteristics | ||
| Cigarettes/day, median (IQR) | 15 (10,20) | 15 (10,20) |
| Carbon monoxide, median (IQR) (n=107) | 10 (6,15) | 9 (7,17) |
| Carbon monoxide < 8 p.p.m., n (%) | 22 (39) | 18 (33) |
| Fagerstrom Test of Nicotine Dependence score, median (IQR) | 4 (2,6) | 4 (3,5) |
| Ladder of change score, median (IQR) | 7 (6,8) | 7 (6,8) |
| Quit importance, median (IQR) | 10 (8,10) | 10 (9,10) |
| Quit confidence, median (IQR) | 8 (5,9) | 8 (5,10) |
| Any past quit attempts, n (%) | 41 (72) | 41 (75) |
| Median duration longest prior quit attempt, weeks (IQR) (n=82) | 9 (1,30) | 4 (1,26) |
| Any other household smoker, n (%) | 34 (60) | 29 (53) |
| Psychiatric comorbidity | ||
| Lifetime major depressive episode, n (%)§ | 12 (21) | 11 (20) |
| Lifetime psychotic disorder, n (%)§ | 9 (16) | 9 (16) |
| Lifetime suicide attempt, n (%) ‖ | 9 (16) | 7 (13) |
| Severe global psychiatric symptoms, n (%)¶ | 9 (16) | 12 (22) |
| Currently receiving psychiatric treatment, n (%) | 24 (42) | 26 (47) |
| Medical comorbidity | ||
| Hypertension, n (%) | 19 (33) | 22 (40) |
| Diabetes, n (%) | 13 (23) | 11 (20) |
| COPD/Asthma, n (%) | 19 (33) | 12 (22) |
| HIV/AIDS | 11 (19) | 10 (18) |
| Substance use characteristics | ||
| Median duration methadone maintenance, years (IQR) | 4 (2,10) | 7 (3,13) |
| Median methadone dose, mg (IQR) | 110 (70,150) | 100 (65,160) |
| Self-reported use of illicit drugs in 30 days prior to baseline, n (%)** | ||
| Heroin | 8 (14) | 5 (9) |
| Other opiates† | 11 (20) | 13 (24) |
| Cocaine (including crack)† | 17 (30) | 8 (15) |
| Marijuana† | 14 (25) | 13 (24) |
| Hazardous alcohol use, n (%)†† | 4 (7) | 9 (16) |
| Clinical sites | ||
| Site 1 | 9 (16) | 7 (13) |
| Site 2 | 32 (56) | 33 (60) |
| Site 3 | 16 (28) | 15 (27) |
†
n=111, data missing for one participant
‡
Living in a shelter, temporary housing, hotel/motel, or on the street
§
Assessed using the Mini-International Neuropsychiatric Interview 6.0.0
‖
Assessed using the Columbia Suicide Severity Scale, a structured interview which assesses suicidal ideation, plans, intent, and behavior
¶
Assessed using the Brief Symptom Inventory Global Severity Index, with scores dichotomized at a T score ≥ 63
**
Assessed using the Addiction Severity Index-Lite. No participants reported amphetamine use
††
Assessed using the Alcohol Use Disorder Identification Test, with hazardous alcohol use defined as a score >= 4 for women or >=8 for men