BackgroundRepetitive transcranial magnetic stimulation (rTMS) is a novel treatment for smoking cessation and delay discounting rate is novel therapeutic target. Research to determine optimal therapeutic targets and dosing parameters for long-term smoking cessation is needed. Due to potential biases and confounds introduced by the COVID-19 pandemic, we report preliminary results from an ongoing study among participants who reached study end prior to the pandemic.MethodsIn a 3 × 2 randomized factorial design, participants (n = 23) received 900 pulses of 20 Hz rTMS to the left dorsolateral prefrontal cortex (PFC) in one of three Durations (8, 12, or 16 days of stimulation) and two Intensities (1 or 2 sessions per day). We examined direction and magnitude of the effect sizes on latency to relapse, 6-month point-prevalence abstinence rates, research burden, and delay discounting rates.ResultsA large effect size was found for Duration and a medium for Intensity for latency to relapse. Increasing Duration increased the odds of abstinence 7–8-fold while increasing Intensity doubled the odds of abstinence. A large effect size was found for Duration, a small for Intensity for delay discounting rate. Increasing Duration and Intensity had a small effect on participant burden.ConclusionFindings provide preliminary support for delay discounting as a therapeutic target and for increasing Duration and Intensity to achieve larger effect sizes for long-term smoking cessation and will provide a pre-pandemic comparison for data collected during the pandemic.Clinical Trial Registration[www.ClinicalTrials.gov], identifier [NCT03865472].
Relapse to smoking continues to be among the most urgent global health concerns. Novel, accessible, and minimally invasive treatments to aid in smoking cessation are likely to improve the reach and efficacy of smoking cessation treatment. Encouraging prospection by decreasing delay discounting (DD) is a new therapeutic target in the treatment of smoking cessation. Two early-stage interventions, delivered remotely and intended to increase prospection, decrease DD and promote cessation are Episodic Future Thinking (EFT) and Future Thinking Priming (FTP). EFT and FTP have demonstrated at least modest reductions in delay discounting, but understanding whether these interventions are internally valid (i.e., are accomplishing the stated intention) is key. This study examined the internal validity of EFT and FTP. Participants (n = 20) seeking to quit smoking were randomly assigned to active or control conditions of EFT and FTP. Linguistic Inquiry Word Count (LIWC2015) was used to examine the language participants used while engaged in the tasks. Results revealed significant differences in the language participants used in the active and control conditions. Women employed more words than men, but no other demographic differences were found in language. The active conditions for both tasks showed a greater emphasis on future orientation. Risk-avoidance was significantly higher in the active vs. control condition for EFT. Remote delivery of both EFT and FTP was valid and feasible as participants adhered to instructions in the remote prompts, and trends in DD were in the expected directions.
BackgroundTranslating repetitive transcranial magnetic stimulation (rTMS) into evidence-based clinical applications relies on research volunteers with different perspectives on the burden of study participation. Additionally, clinical applications of rTMS require multiple visits over weeks or months, the impact of research burden is an important component for these studies and translation of these findings to clinical practice. High frequency rTMS has significant potential to be developed as an evidence-based treatment for smoking cessation, however, the optimal rTMS dosing strategies have yet to be determined. Participant burden is an important component of determining optimal dosing strategy for rTMS as a treatment for long-term smoking cessation.MethodsIn this double-blinded, sham-controlled, randomized design, the effects of treatment duration, intensity, and active/sham assignment of rTMS on research burden were examined.ResultsOverall level of perceived research burden was low. Experienced burden (M = 26.50) was significantly lower than anticipated burden (M = 34.12). Research burden did not vary by race or income.ConclusionsOverall research burden was relatively low. Contrary to our hypotheses, we found little evidence of added significant burden for increasing the duration or intensity of rTMS, and we found little evidence for differences in research burden by race or income.Clinical Trial Registrationidentifier NCT03865472.
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