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The success of modern medicine creates a growing population of those suffering from life-threatening illnesses (LTI) who often experience anxiety, depression, and existential distress. We present a novel approach; investigating MDMA-assisted psychotherapy for the treatment of anxiety in people with an LTI. Participants with anxiety from an LTI were randomized in a double-blind study to receive MDMA (125 mg, n = 13) or placebo (n = 5) in combination with two 8-h psychotherapy sessions. The primary outcome was change in State-Trait Anxiety Inventory (STAI) Trait scores from baseline to one month post the second experimental session. After unblinding, participants in the MDMA group had one open-label MDMA session and placebo participants crossed over to receive three open-label MDMA sessions. Additional follow-up assessments occurred six and twelve months after a participant’s last experimental session. At the primary endpoint, the MDMA group had a greater mean (SD) reduction in STAI-Trait scores, − 23.5 (13.2), indicating less anxiety, compared to placebo group, − 8.8 (14.7); results did not reach a significant group difference (p = .056). Hedges’ g between-group effect size was 1.03 (95% CI: − 5.25, 7.31). Overall, MDMA was well-tolerated in this sample. These preliminary findings can inform development of larger clinical trials to further examine MDMA-assisted psychotherapy as a novel approach to treat individuals with LTI-related anxiety.Trial Registration: clinicaltrials.gov Identifier: NCT02427568, first registered April 28, 2015.

Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with severe PTSD, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma. After psychiatric medication washout, participants (n = 90) were randomized 1:1 to receive manualized therapy with MDMA or with placebo, combined with three preparatory and nine integrative therapy sessions. PTSD symptoms, measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5, the primary endpoint), and functional impairment, measured with the Sheehan Disability Scale (SDS, the secondary endpoint) were assessed at baseline and at 2 months after the last experimental session. Adverse events and suicidality were tracked throughout the study. MDMA was found to induce significant and robust attenuation in CAPS-5 score compared with placebo (P

Background: Posttraumatic stress disorder (PTSD) is a debilitating mental health condition associated with serious adverse health outcomes and functional impairment. Previous MDMA–assisted therapy (MDMA-AT) studies have shown promising results in single site studies. Two open-label studies tested this modality in multisite clinical trials to assess the feasibility of scaling this manualized therapy across 14 North American sites. Method: Cotherapist dyads were trained in the manualized MDMA-AT protocol and administered three experimental sessions 3 to 5 weeks apart among participants with severe PTSD. Cotherapist dyads were provided clinical supervision and evaluated for protocol adherence by centralized raters. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) assessed change in symptoms severity. Results: Adherence rating scores were high across cotherapist dyads ( M = 95.08%, SD = 3.70%) and sites ( M = 95.23%, SD = 2.20%). CAPS-5 scores decreased following 3 MDMA-AT sessions at 18 weeks post baseline (Δ M = −29.99, Δ SD = 13.45, p < .0001, n = 37, Cohen’s d = 2.2, confidence interval [1.97, 2.47]). MDMA was well tolerated. Conclusions: These findings corroborate previous results that MDMA-AT can achieve significant improvements in PTSD symptom severity and demonstrate scalability of manualized therapy across clinic sites in the United States and Canada.

The purpose of this exploratory study was to analyze the writing experiences of eighth-grade students in three social studies classrooms while using a Web 2.0 online writing workspace. Participants included one social studies teacher and 69 eighth-grade students in a selective admission public high school. Furthermore, three of the eighth-grade students were chosen as case studies to allow for a more detailed exploration of their writing processes within the online environment. The project was guided by the Common Core Writing Standards for Literacy in History/Social Studies, and objectives were to enhance the students' literacy skills and knowledge acquisition by having students create a wiki-like project. The author proposes that the online writing project and environment allowed students in the social studies class to extend their learning and make connections to outside sources in an accessible manner. The students took ownership over their own learning within their topics and were able to extend and show proficiency in understanding their topics and also in the use of online tools and other Web 2.0 technologies.

The distinction between prevention and detection behaviors provides a useful guideline for appropriately framing health messages in terms of gains or losses. However, this guideline assumes that everyone perceives the outcomes associated with a behavior in a consistent manner, as prevention or detection. Individuals' perceptions of a behavior vary, and so the effects of framed messages may be optimized by considering individuals' perceptions rather than the prevention or detection function of the behavior. The authors tested this message-framing paradigm in a secondary analysis of data from a trial evaluating gain-framed smoking cessation counseling delivered through a state quitline (Toll et al., 2010 ). Smokers (N = 2,032) who called a state quitline received either gain-framed or standard care messages. Smokers' beliefs about the positive consequences of stopping smoking (outcome expectancies) were evaluated at baseline. Smoking status and self-efficacy were assessed at 3 months. Outcome expectancies moderated the framing effects among men but not among women. Men in the gain-framed counseling condition who had positive outcome expectancies were more likely to quit and had more confidence in their ability to quit or to remain abstinent than men who were uncertain of the positive outcome of smoking cessation. Among men, self-efficacy mediated the moderated framing effects of the intervention on quit status. These findings suggest that it may be useful to consider sex and individual differences in outcome expectancies when delivering gain-framed smoking cessation messages in the context of a state quitline.

BACKGROUND: Based on published data showing that daily smokers have high rates of hazardous drinking and higher rates of smoking relapse, we hypothesized that New York State Smokers' Quitline (NYSSQL) callers would exhibit elevated rates of risky drinking and risky drinking callers would report lower rates of smoking cessation. METHODS: We assessed rates of hazardous drinking among 88,479 callers to the NYSSQL using modified NIAAA guidelines. Using 2 routine NYSSQL short-term follow-up interviews (n = 14,123 and n = 24,579) and a 3-month follow-up interview (n = 2,833), we also compared smoking cessation rates for callers who met criteria for hazardous drinking compared to moderate drinkers and nondrinkers. RESULTS: At baseline, 56% of callers reported drinking, and 23% reported hazardous drinking using modified NIAAA guidelines. Hazardous drinkers did not differ on measures of smoking cessation outcomes compared to nondrinkers but did have lower smoking cessation rates compared to persons who reported moderate alcohol consumption for the enhanced services program 1-week follow-up (adjusted OR [95% CI] = 1.09 [1.01, 1.17], p = 0.04) and the standard 2-week follow-up (adjusted OR [95% CI] = 1.17 [1.07, 1.29], p = 0.001). CONCLUSIONS: Nearly a quarter of smokers calling the NYSSQL reported a hazardous drinking pattern, which was associated with lower cessation outcomes compared to those who reported a moderate drinking profile. Given the large number of high-risk drinkers who can be identified through a quitline, tobacco quitlines may provide a venue for providing brief alcohol interventions to these high-risk drinkers. Future studies should evaluate whether a brief alcohol intervention would result in improved smoking cessation rates for hazardous drinking smokers. Language: en

Background Previous studies have found that offering additional callback counseling support to smokers calling a telephone quit line increases quit rates. However, what is less certain is the most cost-efficient protocol for offering such a service. Objective This study compares the efficacy of offering 2 versus 4 counseling callbacks after an initial call from Medicaid/uninsured adult smokers contacting the New York State Smokers' Quit Line (NYSSQL). Outcomes compared are the 7- and 30-day nonsmoker prevalence rates measured at 3-month follow-up and the cost per quit. Design A 2-group randomized trial was conducted. Setting and participants The study population included 1923 adult (18+ years) Medicaid/uninsured current smokers (10+ cigarettes per day) who called the NYSSQL between February and March 2009 seeking help to stop smoking. At the time of the study, the NYSSQL provided Medicaid/uninsured callers with up to 6 weeks of free nicotine medications and up to 4 counseling callbacks. Half the subjects were randomized to standard care with up to 4 counseling callbacks with the remaining subjects offered only 2 counseling callbacks. All participants were sent a minimum of a 2-week supply of nicotine replacement therapy, with some receiving up to 6 weeks. Participants were recontacted 3 months after enrollment in the study to assess smoking status. Main outcome measures Quit rates, total counseling callbacks completed, reductions in cigarette consumption, and cost per quit measures. Results There was not a significant difference between study groups in the number of callbacks completed. There was also no difference in 7- or 30-day nonsmoker prevalence rates measured after 3 months' follow-up or reported use of the free nicotine replacement therapy between those assigned to either the 2- or 4-callback protocols. The cost per quit was essentially the same in both groups (2 callbacks--$442 per quit vs 4 callbacks--$445 per quit). Conclusion There was no advantage in terms of quit success or cost to offering up to 4 callbacks instead of 2 callbacks.

Results Specialists providing gain-framed counseling used gain-framed statements statistically significantly more frequently than those providing standard-care counseling as assessed with frequency ratings for the two types of gain-framed statements, achieving benefits and avoiding negative consequences (for achieving benefits, gainframed mean frequency rating = 3.9 vs standard-care mean frequency rating = 1.4; mean difference = 2.5; 95% confidence interval [CI] = 2.8 to 2.3; P < .001; for avoiding negative consequences, gain-framed mean frequency rating = 1.5 vs standard-card mean frequency rating = 1.0; mean difference = 0.5; 95% CI = 0.6 to 0.3; P < .001). Gain-framed counseling was associated with a statistically significantly higher rate of abstinence at the 2-week follow-up (ie, 99 [23.3%] of the 424 in the gain-framed group vs 76 [12.6%] of the 603 in the standard-care group, P < .001) but not at the 3-month follow-up (ie, 148 [28.4%] of the 522 in the gain-framed group vs 202 [26.6%] of the 760 in the standard-care group, P = .48). Conclusions Quitline specialists can be trained to provide gain-framed counseling with good fidelity. Also, gain-framed messages appear to be somewhat more persuasive than standard-care messages in promoting early success in smoking cessation. J Natl Cancer Inst 2010;102:96–106

Objective To estimate the effectiveness of a free nicotine patch giveaway program offered to New York City (NYC) smokers conducted in 2003. Methodology The effectiveness of the program was assessed by contrasting the 12-month quit rate of program participants with the quit rate from a group of Quitline callers who were not offered free nicotine patches. The follow-up surveys were conducted in 2004 and the analysis in 2005. Results The 7-day nonsmoking prevalence rate measured at 12 months among callers who received the nicotine patches was 1.78 times higher (95% confidence interval [CI]=1.19–2.66) than the quit rate among a comparable group of callers to the Quitline from NYC a year earlier who did not receive nicotine patches. Conclusions The provision of free nicotine patches through a telephone quitline was effective in inducing a large number of smokers to make a quit attempt and stop smoking, above and beyond the efficacy of the quitline support alone.

In an effort to increase access to evidence-based smoking cessation therapies, regional tobacco control programs in New York State implemented different interventions to make free nicotine patches and gum available to smokers wishing to quit. In one region, eligible smokers were sent a voucher redeemable at a local pharmacy for a 2-week supply of either nicotine patches or gum. In other regions, smokers received either a 1-week supply or a 2-week supply of nicotine patches sent to their home. In New York City, eligible smokers received a 6-week supply of nicotine patches and a follow-up phone call. All of the programs utilized the state's Smokers' Quitline to screen and register eligible smokers for the free medication. The reach of the different programs was evaluated by computing the proportion of eligible smokers within a given area enrolled in the program and tracking call volume to the Quitline before, during, and after the free giveaway promotions. Efficacy was evaluated by a telephone follow-up survey of program participants conducted 4 months after enrollment to measure use of the medications and smoking behavior. The quit rate of program participants was contrasted with the quit rate computed from an earlier follow-up survey of Quitline callers who were not provided nicotine replacement therapy (NRT). Free nicotine patches or gum was sent to 40,090 smokers representing about 2.9 percent of eligible heavy smokers (10+ cigarettes per day) in the state. In each time period and location where free NRT was offered, call volume to the Quitline increased dramatically. Quit rates varied in relationship to the supply of NRT sent to participants, but in all cases was higher than the quit rate observed among smokers not sent NRT (21%-35% vs 12%). The offer of free NRT appears to be a cost-effective method to induce large numbers of smokers to make a quit attempt.

In an effort footline to motivate smokers across New York State to stop smoking, tobacco control programs across the state held 'Quit and Win' incentive-based stop-smoking contests. These contests encouraged smokers to make a quit attempt by offering a chance to win cash prize (usually 1,000 dollars) for successfully stopping smoking for at least 1 month. Between 2001 and 2004, 11 different Quit and Win Contests involving 5,504 adult smokers were sponsored in different communities across New York State. Follow-up surveys were conducted 4 to 6 months after each contest ended to evaluate participants' success in quitting smoking. Expenditures for promoting contests varied from a high of 91,441 dollars to a low of 4,345 dollars, with a median of 25,928 dollars. An average of 0.55 percent of smokers was recruited to join contests across the 11 communities. Among smokers who enrolled in a contest, 9 out of 10 reported making a quit attempt, and between 53 percent and 72 percent reported quitting for the full month of the contest. At 4 to 6 months follow-up, self-reported quit rates (7-day point prevalence) among contestants ranged from 22 percent to 49 percent, with an average of 31 percent. Based on a statewide population survey, 8 of the 11 programs showed quit rates that were significantly higher (P < .001 by Wilcoxon rank-sum test) than the estimated quit rate of 21 percent seen among smokers making a quit attempt in the past year. This study shows that for a relatively modest investment of resources, thousands of smokers can be recruited to make a serious quit attempt, with many remaining smoke-free months later.

BACKGROUND With an increasing prevalence of lighter smokers presenting for cessation assistance, outcome-based recommendations are needed to inform nicotine replacement therapy (NRT) distribution protocols by quitlines. METHODS A quasi-experimental design was utilized to compare quit rates based on samples selected from the time period before and after NRT (gum or lozenge) was offered to light daily smokers (1-9 cigarettes) contacting the New York State Smokers' Quitline. Outcome measures included self-reported 7- and 30-day abstinence rates, numbers of daily cigarettes among continuing smokers, and cost per quit analyses. RESULTS Among responders to the follow-up survey, quit rates were higher for those given NRT compared with those not offered NRT at both 7 (33.0% vs. 27.2%; Relative Risk [RR] = 2.25 [95% CI: 1.15, 4.40; p < .05]) and 30 days (28.0% vs. 21.9%; RR = 2.63 [95% CI: 1.25, 5.54; p < .05]). Similar results were obtained based on intent-to-treat analyses for both 7 (13.4% vs. 11.3%; RR = 1.92 [95% CI: 1.08, 3.39; p < .05]) and 30 days (11.4% vs. 9.1%; RR = 2.29 [95% CI: 1.20, 4.40; p < .05]). Among continuing smokers, the mean number of cigarettes smoked per day increased from enrollment to follow-up in both groups, but less so in those receiving NRT. The additional cost associated with providing a 2-week free supply of nicotine replacement to smokers was $52 for gum and $74 for lozenge. CONCLUSIONS This study demonstrates that light daily smokers (1-9 cigarettes) who contact a telephone quitline are interested in using NRT if offered and are able to achieve higher quit rates compared with those not offered NRT.

Background Many telephone quit lines provide free nicotine replacement therapy (NRT) to smokers who are trying to stop smoking. However, providing free NRT to smokers can be costly. Objective To compare NRT usage patterns, quit rate, and costs of giving smokers calling a telephone quit line different amounts of free NRT. Design A 3-group randomized trial was conducted. Setting and participants A total of 2806 adult smokers of 10+ cigarettes per day who called the New York State Smokers' Quit Line (NYSSQL) were sent different amounts of nicotine patches for free as follows: (1) a 2-week supply of nicotine patches, (2) a 4-week supply, and (3) a 6-week supply. In addition, all study participants received a free stop smoking guide plus 1 proactive follow-up call attempt conducted 2 weeks after initially contacting the NYSSQL. Of the 2806 enrolled participants, 1682 completed the 7-month follow-up to assess their use of the NRT sent to them and smoking status. Main outcome measures Nicotine patch usage, quit rates, reductions in cigarette consumption, and cost-effectiveness measures. Results Most respondents (85%) reported using the nicotine patches sent to them, although the amount used varied in direct proportion to the amount sent. The 7- and 30-day nonsmoker prevalence rates measured at 7-month follow-up did not differ significantly between the 3 groups. The cost per attributable quit was also not significantly different between the 3 groups. Conclusion Sending out more than a free 2-week supply of patches to smokers who contact a quit line is no more effective in achieving smoking cessation than sending just 2 weeks of patches.

High nicotine dependence is a reliable predictor of difficulty quitting smoking and remaining smoke-free. Evidence also suggests that the effectiveness of various smoking cessation treatments may vary by nicotine dependence level. Nicotine dependence, as assessed by Heaviness of Smoking Index baseline total scores, was evaluated as a potential moderator of a message-framing intervention provided through the New York State Smokers’ Quitline (free telephone based service). Smokers were exposed to either gain-framed ( n = 810) or standard-care ( n = 1222) counseling and printed materials. Those smoking 10 or more cigarettes per day and medically eligible were also offered a free 2-week supply of nicotine patches, gum, or lozenge. Smokers were contacted for follow-up interviews at 3 months by an independent survey group. There was no interaction of nicotine dependence scores and message condition on the likelihood of achieving 7-day point prevalence smoking abstinence at the 3-month follow-up contact. Among continuing smokers at the 3-month follow-up, smokers who reported higher nicotine dependence scores were more likely to report smoking more cigarettes per day and this effect was greater in response to standard-care messages than gain-framed messages. Smokers with higher dependence scores who received standard-care messages also were less likely to report use of nicotine medications compared with less dependent smokers, while there was no difference in those who received gain-framed messages. These findings lend support to prior research demonstrating nicotine dependence heterogeneity in response to message framing interventions and suggest that gain-framed messages may result in less variable smoking outcomes than standard-care messages.

Telephone quitlines efficiently deliver cessation services, but few smokers use them. This article describes an unsolicited direct mail campaign designed to increase calls to the New York State Smokers' Quitline. Two post-cards advertising the quitline and the availability of free nicotine patches were sent to 77,527 smoker households between August and October 2005. One postcard emphasized the effectiveness of the nicotine patch, whereas the other contrasted the risks of smoking and patch use. Response was evaluated using geographically linked calls to the quitline 15 days before and after each mailing. The postcard campaign increased call volume by 36%, with no difference between the two postcard versions. Those who reported calling the quitline in response to a mailing were more likely to request nicotine patches (91% versus 82%, p < .001). Direct mail can be used to increase quitline call volume and should be one of the promotional tools used by quitlines.

This article presents results from two population-based promotions for free cessation products used to induce smokers to call the New York State Smokers'. The first promotion was a press announcement urging smokers to call the quitline to get a voucher for a free 2-week supply of nicotine patches or gum (nicotine replacement therapy [NRT]). The second promotion involved comparing response to two newspaper advertisements for the quitline, one of which offered a free stop smoking guide and one that offered the guide plus a free stop smoking aide called Better Quit (BQ). Responses to each promotion were monitored by tracking the call volume to the quitline-before, during, and after each of the promotions. The NRT voucher promotion increased median call volume 25-fold compared to prepromotion levels, whereas the BQ newspaper advertisement increased median call volume 2-fold compared to a newspaper advertisement for the quitline, which did not offer BQ. A random sample of 732 smokers who received the free NRT voucher were followed up 4 to 6 months later to determine their use of NRT and smoking behavior. Embedded within this follow-up study was a randomized experiment in which half the smokers were mailed a quit kit with BQ included and the other half received just the quit kit. Seventy percent of follow-up survey respondents said that they had redeemed the NRT voucher and used the medication to try to quit smoking. Twenty-two percent reported they were no longer smoking, compared with the 12 percent among a comparison group of quitline callers who had not received the free NRT voucher (odds ratio = 1.77; 95% confidence interval: 1.17-2.68). There was no difference in quit rates between those that were sent the BQ cigarette substitute and those that did not get the BQ. This study shows that offering a free 2-week voucher for NRT is a cost-effective method to increase calls to a stop smoking quitline and may also increase the odds of quitting for those who get the free NRT.

To estimate the effectiveness of a free nicotine patch giveaway program offered to New York City (NYC) smokers conducted in 2003.The effectiveness of the program was assessed by contrasting the 12-month quit rate of program participants with the quit rate from a group of Quitline callers who were not offered free nicotine patches. The follow-up surveys were conducted in 2004 and the analysis in 2005.The 7-day nonsmoking prevalence rate measured at 12 months among callers who received the nicotine patches was 1.78 times higher (95% confidence interval [CI] = 1.19-2.66) than the quit rate among a comparable group of callers to the Quitline from NYC a year earlier who did not receive nicotine patches.The provision of free nicotine patches through a telephone quitline was effective in inducing a large number of smokers to make a quit attempt and stop smoking, above and beyond the efficacy of the quitline support alone.

An error has been noted in the above mentioned article by Krupski et al. In the discussion section in the fourth paragraph, ‘greater than 15 cigarettes per day’ should read ‘greater than or equal to 10 cigarettes per day’.