A randomized controlled trial of intermittent theta burst stimulation to the medial prefrontal cortex for tobacco use disorder: Clinical efficacy and safety.

OBJECTIVE: This study aimed to evaluate the clinical efficacy and safety of administering intermittent theta burst stimulation (iTBS) to the medial prefrontal cortex for tobacco use disorder. METHODS: A randomized sham-controlled trial was conducted, with 38 participants receiving 28 sessions of active (n=25) or sham (n=13) iTBS (2 sessions/day, 600 pulses/session, 110% resting motor threshold, AFz target) along with smoking cessation education (Forever Free © booklets) over 14 visits. Primary outcomes included self-reported cigarette consumption and abstinence, verified by urinary cotinine tests. Secondary outcomes included symptoms of tobacco use disorder, negative mood, and safety/tolerability. RESULTS: Both active and sham groups reported reduced cigarette consumption (ß = -0.12, p = 0.015), cigarette craving (ß = -0.16, p = 0.002), and tobacco withdrawal symptoms (ß = -0.05, p < 0.001). However, there were no significant time x group interaction effects for any measure. Similarly, the two groups had no significant differences in urinary cotinine-verified abstinence. Adverse events occurred with similar frequency in both groups. CONCLUSION: There were no differences in cigarette consumption between the active and sham iTBS groups, both groups decreased cigarette consumption similarly. Further research is needed to compare iTBS to standard high-frequency rTMS and explore the potential differences in efficacy. Despite limitations, this study contributes to experimental design considerations for TMS as a novel intervention for tobacco and other substance use disorders, emphasizing the need for a more comprehensive understanding of the stimulation parameters and target sites.

Psychosocial Indicators of Adolescent Alcohol, Cigarette, and Marijuana Use: An Analysis of Normalized, Harmonized, and Pooled Data.

We normalized, harmonized, and pooled 344,429 surveys collected from 106,470 research participants from 25 research studies that assessed past 30-day alcohol use, drunkenness, smoking cigarettes, using marijuana, and a host of psychosocial variables. After normalizing and harmonizing psychosocial measures, we completed analyses to examine the ability of psychosocial variables to serve as proxy indicators of use. Intentionality, peer descriptive normative beliefs, and age emerged as being of primary importance in indicating use. Additional variables - peer injunctive norms, beliefs about the positive and negative consequences of use, and attitudes - were also demonstrated to have the potential to serve as proxies in the assessment of substance use risk. There were developmental patterns in how intentionality and descriptive normative beliefs changed with age. Young adolescents had scores that are protective; they have positive intentionality and do not see the prevalence of alcohol and other drug use as widespread. These and other psychosocial variable's mean scores generally erode with age while the distribution of scores widens as youth grow older. The goal of analyses was to define age-related psychosocial profiles that can be used prospectively to estimate substance use risk. These profiles are useful in creating virtual control cases for evaluating disseminated prevention programs.