Psilocybin-assisted treatment for Nicotine Dependence

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Nicotine Dependence+1 More
Psilocybin-assisted treatment - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether psilocybin may help individuals quit smoking.

See full description

Eligible Conditions

  • Nicotine Dependence

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

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..

Month 3
MRI scanning
Month 12
Urinary cotinine
Month 12
Breath CO

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Nicotine Replacement Therapy (NRT)
1 of 2
Psilocybin-assisted treatment
1 of 2
Active Control
Experimental Treatment

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.

Psilocybin-assisted treatment
Drug
Participants will receive a 13-week cognitive behavioral intervention for smoking cessation, with a high dose of psilocybin (30mg / 70kg) to be administered on the Target Quit Date in week 5.
Nicotine Replacement Therapy (NRT)
Drug
Participants will receive a 13-week cognitive behavioral intervention for smoking cessation, with a standard 8 to 10-week regimen of NRT to be administered beginning on the Target Quit Date in week 5. NRT for this study will be a transdermal nicotine patch administered according to recommended label usage (For individuals who smoke more than 10 cigarettes per day: 21mg daily weeks 1-6, 14mg daily weeks 7-8, 7mg daily weeks 9-10. For individuals who smoke 10 or less cigarettes per day: 14mg daily for weeks 1-6, 7mg daily for weeks 7-8).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 2 weeks (pre), 5 weeks (post), and 3 month follow up (for individuals still abstinent at this time point)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at 2 weeks (pre), 5 weeks (post), and 3 month follow up (for individuals still abstinent at this time point) for reporting.

Closest Location

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The volunteer must agree to consume approximately the same amount of caffeine as he or she usually does before arriving at the research unit on the day of the drug session show original
If you've smoked cigarettes every day for years, unsuccessfully tried to quit multiple times, and still want to quit, varenicline may be a good medication choice for you. show original
Please refrain from smoking, alcohol, and caffeine for 24 and 12 hours, respectively, prior to your MRI scan. show original
I agree not to smoke anything for one hour before taking psilocybin and to not smoke anything for 30 hours afterwards. show original
I agree not to use any psychoactive drugs, including alcoholic beverages, within 24 hours of taking psilocybin show original
The text discusses the age range 21 to 65 years old. show original
I have given written consent. show original
Have finished high school. show original
Be healthy as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests.

Patient Q&A Section

Can tobacco dependence be cured?

"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

Unverified Answer

How many people get tobacco dependence a year in the United States?

"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

Unverified Answer

What is tobacco dependence?

"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

Unverified Answer

What are common treatments for tobacco dependence?

"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

Unverified Answer

What are the signs of tobacco dependence?

"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

Unverified Answer

What causes tobacco dependence?

"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

Unverified Answer

How serious can tobacco dependence be?

"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

Unverified Answer

What does psilocybin-assisted treatment usually treat?

"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

Unverified Answer

How does psilocybin-assisted treatment work?

"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

Unverified Answer

What is the primary cause of tobacco dependence?

"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

Unverified Answer

What are the latest developments in psilocybin-assisted treatment for therapeutic use?

"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

Unverified Answer

Does tobacco dependence run in families?

"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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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