This trial is evaluating whether Psilocybin-assisted treatment will improve 3 primary outcomes in patients with Nicotine Dependence. Measurement will happen over the course of For 13 weeks during active treatment, then at 3, 6, and 12 month follow up..
This trial requires 95 total participants across 2 different treatment groups
This trial involves 2 different treatments. Psilocybin-assisted Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.
"The treatment of tobacco [smoking cessation](https://www.withpower.com/clinical-trials/smoking-cessation) can be achieved independently of smoking cessation treatment. However, the treatment of nicotine dependence can be improved since it is associated with a large decrease in the intensity of smoking and it is associated with improved outcome in tobacco users independent of smoking cessation treatment in smokers with nicotine dependence." - Anonymous Online Contributor
"The estimated prevalence of tobacco dependence among U.S. adults is 9.2% in 2002, with an estimated 18 million smokers. While the prevalence of tobacco dependence has significantly increased among young tobacco users, it is lower among those older than 60." - Anonymous Online Contributor
"It is estimated that approximately one-third of adult cigarette smokers use other forms of tobacco at some time during the course of a year. Tobacco dependence is associated with increased cigarette smoking and risk-taking behaviours, lower social class, lower levels of income and schooling, poor health-related quality of life, and greater morbidity and mortality." - Anonymous Online Contributor
"Different treatment options exist for cigarette, cigar, smokeless tobacco, and chewing tobacco use. Common options include pharmacologic and behavioral treatments, group psychotherapy, and complementary and alternative medicine modalities." - Anonymous Online Contributor
"A number of physical and psychological symptoms could be present. This may increase as dependence is more severe in cigarette smokers. The use of alcohol with tobacco, and the number of cigarettes smoked per day are the most important determinants of the symptomatology." - Anonymous Online Contributor
"The most frequently accepted theory that tobacco dependence is the result of epigenetic changes in the brain is discussed. It is not an adequate explanation for the development of nicotine dependence or the development of the epigenetic changes. We have also found evidence that the development of nicotine dependency does not only depend on the individual's genome but also on how it gets translated into a phenotype by its environment. The data indicates that changes in the environment should be considered as major factors that affect the development of nicotine dependence." - Anonymous Online Contributor
"Findings from a recent study suggest that individuals in many countries may have nicotine dependence, but that the seriousness of dependence varies widely among individuals. Therefore, it is important to specify severity measures, which may be used to guide tobacco control efforts and interventions." - Anonymous Online Contributor
"Psilocybin-assisted treatment is effective for a wide range of problems, including substance dependence. Patients find these procedures effective; clinicians, however, must learn how to integrate the psychotherapeutic, psychological, and pharmacological techniques into patient management." - Anonymous Online Contributor
"There are various factors that contribute substantially to the success or failure of TAAD: baseline factors that determine adherence to treatment and maintenance conditions or factors related to the drug regimen. This trial highlights the potential benefits of TAAD (i.e., a psychotherapy + 5-day course of psilocybin) with regard to smoking; it shows that TAAD can reduce or abstain from tobacco with the potential for lasting effects. Recent findings suggest that TAAD merits further investigation with smokers." - Anonymous Online Contributor
"This investigation supports the hypothesis that many smokers may have developed tobacco dependence primarily under the influence of environmental cues, such as peers and family members, and not under the influence of nicotine." - Anonymous Online Contributor
"The evidence is currently quite sparse on the efficacy and tolerability of the use of psilocybin as a treatment in its own right, in contrast to its potential role as an adjunct to other treatments when added to a standard therapeutic program. Further research in this field may clarify the role of psilocybin treatment as a first-line treatment or as an adjunct treatment for patients who have failed other traditional pharmacological interventions." - Anonymous Online Contributor
"It would appear some of the risk for developing regular cigarettes is genetically determined, but this predisposition can be overcome with prolonged exposure to light levels. The findings for parental use of nicotine dependence treatments indicate the need to make a concerted effort, in terms of education and treatment of both spouses of those with regular cigarette use." - Anonymous Online Contributor