Effects of Psilocybin in Anorexia Nervosa
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04052568|
Recruitment Status : Recruiting
First Posted : August 12, 2019
Last Update Posted : September 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anorexia Nervosa||Drug: Psilocybin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Psilocybin in Anorexia Nervosa|
|Actual Study Start Date :||August 26, 2019|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Experimental psilocybin
Participants will have two sessions of psilocybin treatment.
Participants will undergo two moderate to high dose psilocybin sessions. Dosing at the first session will be the lesser of 20 mg or 0.6 mg/kg. For the second session participants will either remain at participants' initial dose, or increase to the lesser of 25 mg or 0.6 mg/kg at the discretion of the study team.
- Change in the State-Trait Anxiety Inventory (STAI) score [ Time Frame: Baseline, 1 week, and 1, 2, 3, and 6 months after second psilocybin session ]The STAI is a 40-item self-report scale that measures both state and trait anxiety. Scores either component range from 20 to 80 with a higher score indicating higher levels of anxiety.
- Change in Hospital Anxiety and Depression Scale (HADS) Score [ Time Frame: Baseline, 1 week, and 1, 2, 3, and 6 months after second psilocybin session ]The HADS is a 14-item self-report questionnaire that assesses both anxiety (7 questions) and depression (7 questions). Each question is scored on a 4-point Likert scale from 0-3, with higher scores indicating more severe symptoms.
- Change in Beck Depression Inventory (BDI) Score [ Time Frame: Baseline, 1 week, and 1, 2, 3, and 6 months after second psilocybin session ]The BDI is a 21-item self-report scale, rating severity of depressive symptoms on a 4-point Likert scale ranging from 0-3. Total scores range from 0-63 with higher scores indicating higher levels of depressive symptoms.
- Change in health related quality of life as assessed by the Eating Disorder Quality of Life Scale (EDQLS) [ Time Frame: Baseline, 1 week, and 1, 2, 3, and 6 months after second psilocybin session ]This is a 40-item self-report measure of health related quality of life that is specifically developed for eating disorder populations. Each question is rated on a 5 point scale from 1-5, with higher scores indicating better quality of life.
- Change in Eating Disorder Examination Questionnaire (EDE-Q) score [ Time Frame: Baseline, 1 week, and 1, 2, 3, and 6 months post second psilocybin session ]This is a 28-item self-report score that measures severity of eating disorder symptoms across four domains that each make up a sub-scale: dietary restraint, eating concern, weight concern, and shape concern. A global score is calculated by averaging sub-scale scores. Sub-scale and global scores range from 0-6 with higher scores indicating higher severity.
- Change in Body mass index (BMI) [ Time Frame: 3 months ]This is a measure of body mass calculated from height and weight (Kg/m^2).
- Change in Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ) score [ Time Frame: Baseline, 1 week, and 1, 2, 3, and 6 months post second psilocybin session ]The ANSOCQ is a 20-item self-administered questionnaire that places respondents in one of the five stages of change based on Prochaska and DiClemente's model. The maximum raw score is 100, with higher scores indicating higher levels of motivation. An overall classification of the stage of change is obtained by dividing the raw score by 5.
- Change in Food preference as assessed by food choice task [ Time Frame: Baseline, 1 and 6 months post second psilocybin session ]The investigators will assess food preference using a validated food choice task in which participants are shown images of a variety of food items and are asked to rate the subjective healthiness and tastiness of each item.
- Change in Food preference as assessed by the Geiselman Food Preference Questionnaire (FPQ) [ Time Frame: Baseline, 1 and 6 months post second psilocybin session ]The Geiselman Food Preference Questionnaire is a validated questionnaire that assesses preference for a variety of foods on a 9-point Likert scale with higher scores indicating higher preference. From these responses, a fat preference score is calculated from responses with a score of <100 indicating below average fat preference, and scores >100 indicating above average fat preference.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04052568
|Contact: Natalie Gukasyan, M.D.||firstname.lastname@example.org|
|United States, Maryland|
|Behavioral Pharmacology Research Unit||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Natalie Gukasyan, M.D. 410-550-2253|
|Principal Investigator:||Roland Griffiths, Ph.D.||Johns Hopkins University|