Litigation

We screened smokers for eligibility online or by phone. We used responses to screening questions to estimate eligible smokers’ usual cigarette consumption and instructed them to bring an 8-day supply of cigarettes to the baseline visit, at which smokers enrolled and provided written informed consent. At this time, we informed participants that the study was examining how smokers understand the labels on their cigarette packs. At this visit, we assigned participants to receive 1 of 8 warnings using simple randomization based on a single allocation ratio. Using a random number generator, we created a randomly ordered, pre-populated list of study conditions and, as participants enrolled in the study, we assigned them to the next study condition on the list. Four pictorial warnings contained text required by the Tobacco Control Act and a picture to illustrate a health harm of smoking selected from the FDA’s originally proposed set of images²² (Figure 1). We chose these 4 warning images because they performed well in a previous internet study and avoided many of the criticisms in the lawsuits (eg, using a cartoon or a rare health harm of smoking).^{23 (link)} We removed the quit line number from the images, which was a source of contention in litigation against the warnings.¹² Four text-only control warnings used the US Surgeon General’s warning statements that have been required on the side of cigarette packs since 1985. Participants attended 4 follow-up visits spaced 1week apart, bringing an 8-day supply of cigarettes to all but the final visit.
Participants completed 2 computer surveys at the baseline visit and 1 survey at each visit thereafter. While participants completed the surveys at these appointments, research staff placed the assigned warnings on participants’ cigarette packs. Participants who missed visits completed the computer survey remotely and did not have their packs labeled that week. For smokers assigned to receive pictorial warnings, research staff removed the package cellophane and applied the self-adhesive labels to the top half of the front and back panels of participants’ cigarette packs, in accordance with the proposed FDA requirements.¹¹ For participants with flip top packs, research staff cut through the label to allow the top to open freely. For smokers assigned to receive text-only warnings, research staff removed the package cellophane and applied the self-adhesive labels on the side of the packs covering the existing US Surgeon General’s warnings. We applied the new warning labels on top of the existing warnings to control for the effect of putting a label on smokers’ packs. Participants received an incorrect label at 0.1% (11 of 7384) of visits during which packs were labeled, but in all cases remained within their assigned trial arm (eg, one pictorial warning instead of another).
Participants received a cash incentive at the end of each visit, up to a total of $185 in North Carolina and $200 in California, depending on the number of surveys completed. Participation incentives were higher in California owing to the higher cost of living there. At the end of the final follow-up appointment, participants received information about local smoking cessation programs.

Participants were women enrolled in seven community-based substance abuse treatment programs (CTPs) across the United States. To be eligible, participants needed to have had at least one traumatic event in their lifetime and to have met DSM-IV-TR (APA, 2000 ) criteria for either full or sub-threshold PTSD. For sub-threshold PTSD, participants had to fulfill DSM-IV-TR criteria A (exposure to a traumatic stressor), B (re-experiencing symptoms), E (symptom duration of at least one month) and F (significant distress or impairment of functioning), and either C (avoidance and numbing symptoms) or D (symptoms of increased arousal), but not both as in full PTSD. This is a commonly used definition of subthreshold PTSD (Blanchard, Hickling, Taylor, Loos, & Gerardi, 1994 ; Grubaugh et al., 2005 (link)). Other inclusion criteria were: 1) between 18–65 years of age; 2) used alcohol or an illicit substance within the past six months and have a current diagnosis of drug or alcohol abuse or dependence; and 3) capable of giving informed consent.
Women were excluded if they had 1) advanced stage medical disease as indicated by global physical deterioration; 2) impaired cognition as indicated by a Mini-Mental Status Exam (Folstein, Folstein, & McHugh, 1975 ) score < 21; 3) significant risk of suicidal/homicidal intent or behavior; 4) history of schizophrenia-spectrum diagnosis; 5) a history of active (past two months) psychosis; 6) involvement in litigation related to PTSD; 7) non English-speaking; or 8) refused to be video- or audio-taped.