Effects of MDMA-assisted therapy for PTSD on self-experience.

INTRODUCTION: There is a resurgence of interest in the therapeutic potential of psychedelic substances such as 3,4-methylenedioxymethamphetamine (MDMA). Primary findings from our randomized, double-blind, placebo-controlled, multi-site Phase 3 clinical trial of participants with severe PTSD (NCT03537014) showed that MDMA-assisted therapy induced significant attenuation in the Clinician-Administered PTSD Scale for DSM-5 compared to Therapy with placebo. Deficits in emotional coping skills and altered self-capacities constitute major obstacles to successful completion of available treatments. The current analysis evaluated the differential effects of MDMA-assisted therapy and Therapy with placebo on 3 transdiagnostic outcome measures and explored the contribution of changes in self-experience to improvement in PTSD scores. METHODS: Participants were randomized to receive manualized therapy with either MDMA or placebo during 3 experimental sessions in combination with 3 preparation and 9 integration therapy visits. Symptoms were measured at baseline and 2 months after the last experimental session using the 20-item Toronto Alexithymia Scale (TAS-20), the 26-item Self Compassion Scale (SCS), and the 63-item Inventory of Altered Self-Capacities (IASC). RESULTS: 90 participants were randomized and dosed (MDMA-assisted therapy, n = 46; Therapy with placebo, n = 44); 84.4% (76/90) had histories of developmental trauma, and 87.8% (79/90) had suffered multiple traumas. MDMA-assisted therapy facilitated statistically significant greater improvement on the TAS-20, the SCS, and most IASC factors of interpersonal conflicts; idealization disillusionment; abandonment concerns; identity impairment; self-awareness; susceptibility to influence; affect dysregulation; affect instability; affect skill deficit; tension reduction activities; the only exception was identity diffusion. CONCLUSION: Compared with Therapy with placebo, MDMA-assisted therapy had significant positive effects on transdiagnostic mental processes of self-experience which are often associated with poor treatment outcome. This provides a possible window into understanding the psychological capacities facilitated by psychedelic agents that may result in significant improvements in PTSD symptomatology.

MDMA-Assisted Therapy for Severe PTSD: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study.

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 < 0.0001, d = 0.91) and to significantly decrease the SDS total score (P = 0.0116, d = 0.43). The mean change in CAPS-5 scores in participants completing treatment was -24.4 (s.d. 11.6) in the MDMA group and -13.9 (s.d. 11.5) in the placebo group. MDMA did not induce adverse events of abuse potential, suicidality or QT prolongation. These data indicate that, compared with manualized therapy with inactive placebo, MDMA-assisted therapy is highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated, even in those with comorbidities. We conclude that MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation. Appeared originally in Nat Med 2021; 27:1025-1033.

MDMA-assisted therapy for posttraumatic stress disorder: A pooled analysis of ethnoracial differences in efficacy and safety from two Phase 2 open-label lead-in trials and a Phase 3 randomized, blinded placebo-controlled trial.

BACKGROUND: Limited ethnoracial diversity in previous ±3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) trials for posttraumatic stress disorder (PTSD) has prompted questions concerning whether Black, Indigenous, and People of Color (BIPOC) also benefit from this treatment. METHODS: Secondary analysis was conducted using a modified intent-to-treat sample pooled from two Phase 2 open-label trials and a Phase 3 randomized, blinded placebo-controlled trial to compare efficacy and safety of MDMA-AT for PTSD between BIPOC and non-Hispanic White participants. Four subgroups were of interest: MDMA-AT, BIPOC (n = 20); MDMA-AT, non-Hispanic White (n = 63); Placebo-assisted therapy (Placebo-AT), BIPOC (n = 17); and Placebo-AT, non-Hispanic White (n = 27). Planned comparisons tested subgroup differences in changes in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) scores from baseline to primary endpoint, controlling for study type and baseline scores. Adverse events (AEs) on the day of (day 0) to 2 days post-dosing were reported for each subgroup. RESULTS: In the MDMA-AT group, no significant ethnoracial difference in CAPS-5 change scores was observed. In the Placebo-AT group, BIPOC participants trended toward greater reductions in CAPS-5 scores than non-Hispanic Whites. Among non-Hispanic Whites, MDMA-AT was accompanied by significantly greater reductions in CAPS-5 scores than Placebo-AT. No treatment difference emerged among BIPOC participants. AEs were mostly rated as mild or moderate across subgroups. CONCLUSIONS: These findings provide preliminary support for the efficacy and safety of MDMA-AT for treating PTSD across ethnoracial groups. There was also a trend toward greater efficacy with Placebo-AT among BIPOC participants. There was an imbalance in subgroups, highlighting the need for culturally responsive recruitment strategies to diversify future studies.

The effects of MDMA-assisted therapy on alcohol and substance use in a phase 3 trial for treatment of severe PTSD.

BACKGROUND: Post-traumatic stress disorder (PTSD) is commonly associated with alcohol and substance use disorders (ASUD). A randomized, placebo-controlled, phase 3 trial demonstrated the safety and efficacy of MDMA-assisted therapy (MDMA-AT) for the treatment of severe PTSD. This analysis explores patterns of alcohol and substance use in patients receiving MDMA-AT compared to placebo plus therapy (Placebo+Therapy). METHODS: Adult participants with severe PTSD (n = 90) were randomized to three blinded trauma-focused therapy sessions with either MDMA-AT or Placebo+Therapy. Eligible participants met DSM-5 criteria for severe PTSD and could meet criteria for mild (current) or moderate (early remission) alcohol or cannabis use disorder; other SUDs were excluded. The current analyses examined outcomes on standardized measures of hazardous alcohol (i.e., Alcohol Use Disorder Identification Test; AUDIT) and drug (i.e., Drug Use Disorder Identification Test; DUDIT) use at baseline prior to randomization and at study termination. RESULTS: There were no treatment group differences in AUDIT or DUDIT scores at baseline. Compared to Placebo+therapy, MDMA-AT was associated with a significantly greater reduction in mean (SD) AUDIT change scores (Δ = -1.02 (3.52) as compared to placebo (Δ = 0.40 (2.70), F (80, 1) = 4.20, p = 0.0436; Hedge's g= .45). Changes in DUDIT scores were not significantly different between treatment groups. CONCLUSIONS: MDMA-AT for severe PTSD may also lead to subclinical improvements in alcohol use. MDMA-AT does not appear to increase risk of illicit drug use. These data provide preliminary evidence to support the development of MDMA-AT as an integrated treatment for co-occurring PTSD and ASUD.

MDMA-assisted therapy significantly reduces eating disorder symptoms in a randomized placebo-controlled trial of adults with severe PTSD.

INTRODUCTION: Eating disorders (EDs) and posttraumatic stress disorder (PTSD) are highly comorbid, yet there are no proven integrative treatment modalities for ED-PTSD. In clinical trials, MDMA-assisted therapy (MDMA-AT) has shown marked success in the treatment of PTSD and may be promising for ED-PTSD. METHODS: Ninety individuals with severe PTSD received treatment in a double-blind, placebo-controlled pivotal trial of MDMA-AT. In addition to the primary (Clinician-Administered PTSD Scale) and secondary (Sheehan Disability Scale) outcome measures, the Eating Attitudes Test 26 (EAT-26) was administered for pre-specified exploratory purposes at baseline and at study termination. RESULTS: The study sample consisted of 58 females (placebo = 31, MDMA = 27) and 31 males (placebo = 12, MDMA = 19) (n = 89). Seven participants discontinued prior to study termination. At baseline, 13 (15%) of the 89 individuals with PTSD had total EAT-26 scores in the clinical range (≥20), and 28 (31.5%) had total EAT-26 scores in the high-risk range (≥11) despite the absence of active purging or low weight. In completers (n = 82), there was a significant reduction in total EAT-26 scores in the total group of PTSD participants following MDMA-AT versus placebo (p = .03). There were also significant reductions in total EAT-26 scores in women with high EAT-26 scores ≥11 and ≥ 20 following MDMA-AT versus placebo (p = .0012 and p = .0478, respectively). CONCLUSIONS: ED psychopathology is common in individuals with PTSD even in the absence of EDs with active purging and low weight. MDMA-AT significantly reduced ED symptoms compared to therapy with placebo among participants with severe PTSD. MDMA-AT for ED-PTSD appears promising and requires further study.

Altered brain activity and functional connectivity after MDMA-assisted therapy for post-traumatic stress disorder.

Introduction: 3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) for post-traumatic stress disorder (PTSD) has demonstrated promise in multiple clinical trials. MDMA is hypothesized to facilitate the therapeutic process, in part, by decreasing fear response during fear memory processing while increasing extinction learning. The acute administration of MDMA in healthy controls modifies recruitment of brain regions involved in the hyperactive fear response in PTSD such as the amygdala, hippocampus, and insula. However, to date there have been no neuroimaging studies aimed at directly elucidating the neural impact of MDMA-AT in PTSD patients. Methods: We analyzed brain activity and connectivity via functional MRI during both rest and autobiographical memory (trauma and neutral) response before and two-months after MDMA-AT in nine veterans and first-responders with chronic PTSD of 6 months or more. Results: We hypothesized that MDMA-AT would increase amygdala-hippocampus resting-state functional connectivity, however we only found evidence of a trend in the left amygdala-left hippocampus (t = -2.91, uncorrected p = 0.0225, corrected p = 0.0901). We also found reduced activation contrast (trauma > neutral) after MDMA-AT in the cuneus. Finally, the amount of recovery from PTSD after MDMA-AT correlated with changes in four functional connections during autobiographical memory recall: the left amygdala-left posterior cingulate cortex (PCC), left amygdala-right PCC, left amygdala-left insula, and left isthmus cingulate-left posterior hippocampus. Discussion: Amygdala-insular functional connectivity is reliably implicated in PTSD and anxiety, and both regions are impacted by MDMA administration. These findings compliment previous research indicating that amygdala, hippocampus, and insula functional connectivity is a potential target of MDMA-AT, and highlights other regions of interest related to memory processes. More research is necessary to determine if these findings are specific to MDMA-AT compared to other types of treatment for PTSD. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT02102802, identifier NCT02102802.

MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.

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 < 0.0001, d = 0.91) and to significantly decrease the SDS total score (P = 0.0116, d = 0.43). The mean change in CAPS-5 scores in participants completing treatment was -24.4 (s.d. 11.6) in the MDMA group and -13.9 (s.d. 11.5) in the placebo group. MDMA did not induce adverse events of abuse potential, suicidality or QT prolongation. These data indicate that, compared with manualized therapy with inactive placebo, MDMA-assisted therapy is highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated, even in those with comorbidities. We conclude that MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation.

The short-term impact of 3 smoked cannabis preparations versus placebo on PTSD symptoms: A randomized cross-over clinical trial.

IMPORTANCE: There is a pressing need for development of novel pharmacology for the treatment of Posttraumatic Stress Disorder (PTSD). Given increasing use of medical cannabis among US military veterans to self-treat PTSD, there is strong public interest in whether cannabis may be a safe and effective treatment for PTSD. OBJECTIVE: The aim of the present study was to collect preliminary data on the safety and potential efficacy of three active concentrations of smoked cannabis (i.e., High THC = approximately 12% THC and < 0.05% CBD; High CBD = 11% CBD and 0.50% THC; THC+CBD = approximately 7.9% THC and 8.1% CBD, and placebo = < 0.03% THC and < 0.01% CBD) compared to placebo in the treatment of PTSD among military veterans. METHODS: The study used a double-blind, cross-over design, where participants were randomly assigned to receive three weeks of either active treatment or placebo in Stage 1 (N = 80), and then were re-randomized after a 2-week washout period to receive one of the other three active treatments in Stage 2 (N = 74). The primary outcome measure was change in PTSD symptom severity from baseline to end of treatment in Stage 1. RESULTS: The study did not find a significant difference in change in PTSD symptom severity between the active cannabis concentrations and placebo by the end of Stage 1. All three active concentrations of smoked cannabis were generally well tolerated. CONCLUSIONS AND RELEVANCE: The present study is the first randomized placebo-controlled trial of smoked cannabis for PTSD. All treatment groups, including placebo, showed good tolerability and significant improvements in PTSD symptoms during three weeks of treatment, but no active treatment statistically outperformed placebo in this brief, preliminary trial. Additional well-controlled and adequately powered studies with cannabis suitable for FDA drug development are needed to determine whether smoked cannabis improves symptoms of PTSD. TRIAL REGISTRATION: Identifier: NCT02759185; ClinicalTrials.gov.

MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study.

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.

Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials.

RATIONALE: Posttraumatic stress disorder (PTSD) is a chronic condition that has wide-ranging negative effects on an individual's health and interpersonal relationships. Treatments with long-term benefits are needed to promote the safety and well-being of those suffering from PTSD. OBJECTIVES: To examine long-term change in PTSD symptoms and additional benefits/harms after 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for treatment of PTSD. METHODS: Participants received two to three active doses of MDMA (75-125 mg) during blinded or open-label psychotherapy sessions with additional non-drug therapy sessions. PTSD symptoms were assessed using the Clinician-Administered PTSD Scale for DSM IV (CAPS-IV) at baseline, 1 to 2 months after the last active MDMA session (treatment exit), and at least 12 months post final MDMA session (LTFU). A mixed-effect repeated-measures (MMRM) analysis assessed changes in CAPS-IV total severity scores. The number of participants who met PTSD diagnostic criteria was summarized at each time point. Participants completed a long-term follow-up questionnaire. RESULTS: There was a significant reduction in CAPS-IV total severity scores from baseline to treatment exit (LS mean (SE) = - 44.8 (2.82), p < .0001), with a Cohen's d effect size of 1.58 (95% CI = 1.24, 1.91). CAPS-IV scores continued to decrease from treatment exit to LTFU (LS mean (SE) = - 5.2 (2.29), p < .05), with a Cohen's d effect size of 0.23 (95% CI = 0.04, 0.43). The number of participants who no longer met PTSD criteria increased from treatment exit (56.0%) to LTFU (67.0%). The majority of participants reported benefits, including improved relationships and well-being, and a minority reported harms from study participation. CONCLUSIONS: PTSD symptoms were reduced 1 to 2 months after MDMA-assisted psychotherapy, and symptom improvement continued at least 12 months post-treatment. Phase 3 trials are investigating this novel treatment approach in a larger sample of participants with chronic PTSD. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00090064, NCT00353938, NCT01958593, NCT01211405, NCT01689740, NCT01793610.

An electronic, smart lighter to measure cigarette smoking: A pilot study to assess feasibility and initial validity.

Understanding variability in smoking patterns may inform smoking cessation interventions. Retrospective reports of cigarettes smoked per day may be biased and typically do not provide temporal precision regarding when cigarettes are smoked. However, real-time, user-initiated tracking, such as logging each time a cigarette is smoked, can be burdensome over long time frames. In this study, adult, non-treatment seeking daily smokers (N = 22) used an electronic, smart lighter to light and timestamp cigarettes for 14 days. Participants reported number of cigarettes smoked per day (CPD) via a mobile device (daily diary) and retrospectively reported CPD at the end of the study using the Timeline Followback (TLFB). Self-reported lighter satisfaction and adherence varied with 68% of participants reporting that they liked using the lighter and participants reporting using the lighter for 92% of cigarettes smoked, on average. Lighter-estimated CPD did not differ from daily diary-estimated CPD, but was significantly lower than TLFB estimates. The lighter resulted in greater day-to-day variability relative to other methods and fewer rounded cigarette counts (digit bias) relative to the TLFB. The lighter appears to be feasible for capturing data on smoking patterns in daily smokers. Though false positive cigarettes are likely low, additional technologies that augment data captured from the lighter may be necessary to reduce false negatives (missed cigarettes) and alternative lighter designs may appeal more to certain smokers.

Cigarette and e-cigarette dual use and risk of cardiopulmonary symptoms in the Health eHeart Study.

E-cigarettes are promoted as healthier alternatives to conventional cigarettes. Many cigarette smokers use both products. It is unknown whether the additional use of e-cigarettes among cigarette smokers (dual users) is associated with reduced exposure to tobacco-related health risks. Cross-sectional analysis was performed using baseline data from the Health eHeart Study, among English-speaking adults, mostly from the United States. Cigarette use (# cigarettes/day) and/or e-cigarette use (# days, # cartridges, and # puffs) were compared between cigarette only users vs. dual users. Additionally, we examined cardiopulmonary symptoms/ conditions across product use: no product (neither), e-cigarettes only, cigarettes only, and dual use. Among 39,747 participants, 573 (1.4%) reported e-cigarette only use, 1,693 (4.3%) reported cigarette only use, and 514 (1.3%) dual use. Dual users, compared to cigarette only users, reported a greater median (IQR) number of cigarettes per day, 10.0 (4.0-20.0) vs. 9.0 (3.0-15.0) (p < .0001), a lower (worse) median (IQR) SF-12 general health score, 3.3 (2.8-3.8) vs. 3.5 (2.8-3.9) (p = .0014), and a higher (worse) median (IQR) breathing difficulty score in the past month, 2.0 (1.0-2.0) vs. 1.0 (1.0-2.0) (p = .001). Of the 19 cardiopulmonary symptoms/ conditions, having a history of arrhythmia was significantly different between cigarette only users (14.2%) and dual users (17.8%) (p = .02). In this sample, dual use was not associated with reduced exposure to either (i) cigarettes, compared to cigarette only users or (ii) e-cigarettes, compared to e-cigarette only users. E-cigarette only use, compared to no product use, was associated with lower general health scores, higher breathing difficulty scores (typically and past month), and greater proportions of those who responded 'yes' to having chest pain, palpitations, coronary heart disease, arrhythmia, COPD, and asthma. These data suggest the added use of e-cigarettes alone may have contributed to cardiopulmonary health risks particularly respiratory health risks.

Relationship between spending on electronic cigarettes, 30-day use, and disease symptoms among current adult cigarette smokers in the U.S.

OBJECTIVE: To examine the relationship between spending on electronic cigarettes (e-cigarettes) and disease symptoms compared with the relationship between 30-day e-cigarette use and disease symptoms among adult cigarette smokers in the U.S. METHODS: We analyzed data from the Tobacco and Attitudes Beliefs Survey which included 533 respondents aged 24+ who were current cigarette smokers and e-cigarette ever users. Fifteen self-reported disease symptoms were included as outcome variables. Separate multivariable logistic regression models were estimated for each disease symptom with total spending on e-cigarettes in the past 30 days and with reported 30-day e-cigarette use. All models controlled for cigarettes smoked per day (CPD) and sociodemographic characteristics. RESULTS: We found that those who spent more on e-cigarettes were more likely to report chest pain (AOR = 1.25, 95% CI 1.02-1.52), to notice blood when brushing their teeth (AOR = 1.23, 95% CI 1.02-1.49), to have sores or ulcers in their mouth (AOR = 1.36, 95% CI 1.08-1.72), and to have more than one cold (AOR = 1.36, 95% CI 1.05-1.78) than those with no spending on e-cigarettes in the past 30 days in an adjusted analysis. After controlling for CPD and other covariates, there were no significant relationships between 30-day e-cigarette use and symptoms. Even after controlling for CPD, e-cigarette expenditures or use was associated with greater odds of wheezing and shortness of breath. CONCLUSIONS: E-cigarette expenditures might be a more useful measure of intensity of e-cigarette use. The additional health effect of e-cigarette use or expenditures among smokers independent of the effect of CPD suggests that e-cigarette use adds adverse health effects even among cigarette smokers.

Mobile and Wearable Device Features that Matter in Promoting Physical Activity.

BACKGROUND: As wearable sensors/devices become increasingly popular to promote physical activity (PA), research is needed to examine how and which components of these devices people use to increase their PA levels. AIMS: (1) To assess usability and level of engagement with the Fitbit One and daily SMS-based prompts in a 6-week PA intervention, and (2) to examine whether use/ level of engagement with specific intervention components were associated with PA change. METHODS: Data were analyzed from a randomized controlled trial that compared (1) a wearable sensor/ device (Fitbit One) plus SMS-based PA prompts, and (2) Fitbit One only, among overweight/ obese adults (N = 67). We calculated average scores from Likert-type response items that assessed usability and level of engagement with device features (e.g., tracker, website, mobile app, and SMS-based prompts), and assessed whether such factors were associated with change in steps/day (using Actigraph GT3X+). RESULTS: Participants reported the Fitbit One was easy to use and the tracker helped to be more active. Those who used the Fitbit mobile app (36%) vs. those who did not (64%) had an increase in steps at 6-week follow-up, even after adjusting for previous web/app use: +545 steps/ day (SE = 265) vs. -28 steps/ day (SE = 242) (p = .04). CONCLUSIONS: Level of engagement with the Fitbit One, particularly the mobile app, was associated with increased steps. Mobile apps can instantly display summaries of PA performance and could optimize self-regulation to activate change. More research is needed to determine whether such modalities might be cost-effective in future intervention research and practice.

Medical marijuana legalization and cigarette and marijuana co-use in adolescents and adults.

BACKGROUND: Medical marijuana legalization is associated with a higher prevalence of marijuana use which may affect cigarette use and nicotine dependence in co-users. In the present study, we examined relationships between statewide legalization of medical marijuana and prevalence of cigarette and marijuana co-use and nicotine dependence in co-using adolescents and adults. METHODS: Data were analyzed from the 2013 National Survey on Drug Use and Health. We compared cigarette and marijuana co-use in the past 30days across age categories (12-64 years) by statewide medical marijuana legalization. Logistic regression models were used to estimate the odds of having nicotine dependence among current cigarette smokers who also reported past 30-day marijuana use and "ever but not current" marijuana use (vs. "never" use) adjusting for covariates including statewide legalization of medical marijuana. RESULTS: Overall, 5.1% of the sample reported past 30-day cigarette and marijuana co-use and a higher proportion of co-users resided in states where medical marijuana was legal compared to illegal (5.8% vs. 4.8%; p=0.0011). Co-use was associated with greater odds of having nicotine dependence compared to cigarette-only use across age categories. Odds were highest and up to 3-times higher in adolescents aged 12-17 years (OR=3.54; 95%CI: 1.81-6.92) and adults aged 50-64 years (OR=3.08; CI: 1.45-6.55). CONCLUSION: Marijuana policy could inadvertently affect cigarette and marijuana co-use and pose challenges to tobacco cessation.

Medical Marijuana Legalization and Co-use in Adult Cigarette Smokers.

OBJECTIVES: We examined effects of long-term medical marijuana legalization on cigarette co-use in a sample of adults. METHODS: We conducted secondary analysis using data from the 2014 US Tobacco Attitudes and Beliefs Survey, which consisted of cigarette smokers, aged ≥ 45 years (N = 506). Participants were categorized by their state residence, where medical marijuana was (1) illegal, (2) legalized < 10 years, and (3) legalized ≥ 10 years. The Web-based survey assessed participants' marijuana use, beliefs and attitudes on marijuana, and nicotine dependence using Fagerstrom Tolerance for Nicotine Dependence (FTND) and Hooked on Nicotine Checklist (HONC) scores. RESULTS: In cigarette smokers aged ≥ 45 years, long-term legalization of medical marijuana was associated with stable positive increases in marijuana use prevalence (ever in a lifetime) (p = .005) and frequency (number of days in past 30 days) (unadjusted p = .005; adjusted p = .08). Those who reported marijuana co-use had greater FTND and HONC scores after adjusting for covariates (p = .05). CONCLUSIONS: These preliminary findings warrant further examination of the potential impact of long-term legalization of medical marijuana on greater cigarette and marijuana co-use in adults and higher nicotine dependence among co-users at the population level.

Wearable Sensor/Device (Fitbit One) and SMS Text-Messaging Prompts to Increase Physical Activity in Overweight and Obese Adults: A Randomized Controlled Trial.

BACKGROUND: Studies have shown self-monitoring can modify health behaviors, including physical activity (PA). This study tested the utility of a wearable sensor/device (Fitbit(®) One™; Fitbit Inc., San Francisco, CA) and short message service (SMS) text-messaging prompts to increase PA in overweight and obese adults. MATERIALS AND METHODS: Sixty-seven adults wore a Fitbit One tracker for 6 weeks; half were randomized to also receive three daily SMS-based PA prompts. The Fitbit One consisted of a wearable tracker for instant feedback on performance and a Web site/mobile application (app) for detailed summaries. Outcome measures were objectively measured steps and minutes of PA by intensity using two accelerometers: Actigraph™ (Pensacola, FL) GT3X+ (primary measure) at baseline and Week 6 and Fitbit One (secondary measure) at baseline and Weeks 1, 2, 3, 4, 5, and 6. RESULTS: Mixed-model repeated-measures analysis of primary measures indicated a significant within-group increase of +4.3 (standard error [SE]=2.0) min/week of moderate- to vigorous-intensity PA (MVPA) at 6-week follow-up (p=0.04) in the comparison group (Fitbit only), but no study group differences across PA levels. Secondary measures indicated the SMS text-messaging effect lasted for only 1 week: the intervention group increased by +1,266 steps (SE=491; p=0.01), +17.8 min/week MVPA (SE=8.5; p=0.04), and +38.3 min/week total PA (SE=15.9; p=0.02) compared with no changes in the comparison group, and these between-group differences were significant for steps (p=0.01), fairly/very active minutes (p<0.01), and total active minutes (p=0.02). CONCLUSIONS: These data suggest that the Fitbit One achieved a small increase in MVPA at follow-up and that the SMS-based PA prompts were insufficient in increasing PA beyond 1 week. Future studies can test this intervention in those requiring less help and/or test strategies to increase participants' engagement levels.

Baseline Depressive Symptoms, Completion of Study Assessments, and Behavior Change in a Long-Term Dietary Intervention Among Breast Cancer Survivors.

BACKGROUND: Depressive symptoms can lower adherence and change in dietary studies. Behavioral activation may reduce these effects. PURPOSE: This study aims to assess relationships among depressive symptoms on adherence and dietary change in the Women's Healthy Eating and Living (WHEL) Study METHODS: Secondary analyses from the WHEL Study, which achieved major dietary change in breast cancer survivors (N = 2817), were conducted. Logistic regressions were undertaken of baseline depressive symptoms (six-item Center for Epidemiologic Studies Depression Scale (CES-D)) with (1) completion of 1- and 4-year study assessments and (2) validated change in dietary behavior in the intervention group. RESULTS: In the comparison group (vs. intervention), depressive symptoms lowered completion of dietary recalls and clinic visits [4 years: odds ratio (OR) = 2.0; 95 % confidence interval (CI) = 1.4-3.0]. The behaviorally oriented intervention achieved major change in those furthest from study targets, although changes were lower in those with depressive symptoms: fruit/vegetable (+37.2 %), fiber (+49.0 %), and fat (-22.4 %). CONCLUSIONS: Behavioral activation in dietary change interventions can overcome the impact of depressive symptoms.

Web-based self-monitoring for weight loss among overweight/obese women at increased risk for breast cancer: the HELP pilot study.

OBJECTIVE: Excess weight and physical inactivity are modifiable risk factors for breast cancer. Training women to use self-help resources over the internet has potential for reducing intervention costs and enhancing maintenance. METHODS: A total of 50 overweight/obese women at increased breast cancer risk were randomized to a 12-week intervention or a comparison group. Telephone-based sessions trained participants to use web-based self-monitoring tools to set goals and track diet and exercise. The comparison group received dietary information but no training. At baseline and 12 weeks, participants were weighed and wore an accelerometer. RESULTS: Participants were aged 60.9 ± 0.8 years with a BMI of 33.1 ± 0.6 kg/m(2). The intervention group lost 3.3 ± 4.0 kg, whereas the comparison group gained 0.9 ± 3.4 kg (p < 0.0001). Intervention participants who found the website helpful lost 5.6 ± 0.7 kg; those who did not lost 0.8 ± 0.9 kg (p < 0.001). Change in physical activity was +70 ± 140 min/week among those who found the website helpful, -6 ± 75 min/week among those who did not, and -34 ± 207 min/week in the comparison group (p < 0.01). CONCLUSIONS: A program to train women to use web-based weight loss tools achieved a substantial short-term weight loss among the majority of participants. Further follow-up is needed to assess weight loss maintenance over time.

Theory-based predictors of influenza vaccination among pregnant women.

BACKGROUND: Guidelines recommend influenza vaccination for pregnant women, but vaccine uptake in this population is far below the goal set by Healthy People 2020. The purpose of this study was to examine predictors of seasonal influenza vaccination among pregnant women. METHODS: Between 2009 and 2012, the Vaccines and Medications in Pregnancy Surveillance System (VAMPSS) conducted a prospective cohort study of influenza vaccine safety among pregnant women in the US and Canada that oversampled vaccinated women. Data for the present paper are from an additional cross-sectional telephone survey completed during the 2010-2011 influenza season. We examined predictors of influenza vaccination, focusing on Health Belief Model (HBM) constructs. RESULTS: We surveyed 199 pregnant women, 81% of whom had received a seasonal influenza vaccine. Vaccination was more common among women who felt more susceptible to influenza (OR=1.82, 95% CI 1.10-3.01), who perceived greater vaccine effectiveness (OR=3.92, 95% CI 1.48-10.43), and whose doctors recommended they have flu shots (OR=3.06, 95% CI 1.27-7.38). Those who perceived greater barriers of influenza vaccination had lower odds of vaccination (OR=0.19, 95% CI 0.05-0.75). Perceived social norms, anticipated inaction regret, and worry also predicted uptake, though demographic characteristics of respondents did not. CONCLUSION: The HBM provides a valuable framework for exploring influenza vaccination among pregnant women. Our results suggest several potential areas of intervention to improve vaccination rates.