Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study

NCT ID: NCT04505189

Last Updated: 2024-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-28
• Study Completion Date: 2024-06-12

Brief Summary

The primary aim of this study is to assess the acceptability and efficacy of treating anorexia nervosa with psilocybin. The secondary aim of this study is to use Magnetic Resonance Imaging (MRI) and Electroencephalography (EEG) to examine the neuronal underpinnings of treatment with psilocybin in this patient group.

Detailed Description

Anorexia nervosa is the most fatal of all psychiatric conditions. With the current paucity of effective pharmacological and psychological treatments, and fewer than half of those diagnosed making a full recovery, there is a great need for new treatment avenues to be explored. For this study, we will recruit patients who have a primary diagnosis of anorexia nervosa as defined by DSM-V criteria, which has been established by their specialist ED team to have been present for at least 3 years, and who have found other forms of treatment ineffective. Over a period of 6 weeks, participants who are deemed eligible at screening will partake in 8 study visits, including three psilocybin dosing sessions with varying doses. The maximum dose of psilocybin a participant will receive in a single session is 25 mg. Across these 8 visits, there will also be 2 MRI scans, up to 5 EEG recordings and a range of psychological measures (questionnaires and interviews). There will be a follow-up period of 12 months following the final study visit.

Conditions

Anorexia Nervosa

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Psilocybin

Group Type: EXPERIMENTAL

Psilocybin

Intervention Type: DRUG

Psilocybin assisted psychotherapy

Interventions

Psilocybin

Psilocybin assisted psychotherapy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Primary DSM-V diagnosis of Anorexia Nervosa

2. Current diagnosis of Anorexia Nervosa, established by specialist eating disorder care team to have likely been present for >3 years

3. Current or past treatments have not been successful to maintain remission from anorexia

4. Be in the care of a GP and specialist eating disorder team in the UK

5. Have a GP and specialist eating disorder team in the UK who can confirm diagnosis

6. Sufficiently competent in English and mental capacity to provide written informed consent

7. BMI ≥14kg/m2 and medically stable

8. Capacity to consent

9. Agree to have us maintain contact with an identified next-of-kin for the duration of the study

10. Agree to have us maintain contact with GP and/or specialist eating disorder team as required, for the duration of the study

Exclusion Criteria

1. Current or previously diagnosed psychotic disorder

2. Immediate family member with a diagnosed psychotic disorder

3. Unstable physical condition e.g., rapid weight loss > 2kg in the prior month

4. Abnormal serum electrolytes, raised cardiac enzymes, hepatic or renal dysfunction

5. MRI or EEG contraindications

6. A history of laxative abuse in the last 3 months (more than twice a week for 3 months)

7. History of serious suicide attempts or presence of a suicide/ serious self-harm risk at screening

8. Currently an involuntary patient

9. Emotionally unstable personality, history of mania, or other psychiatric problem that the screening clinician feels may jeopardise the therapeutic alliance and/or safe exposure to psilocybin

10. Blood or needle phobia

11. Positive pregnancy test at screening or during the study, or woman who are breastfeeding

12. If sexually active, participants who lack appropriate contraceptive measures

13. Drug or alcohol dependence within the last 6 months

14. No email access

15. Patients presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 470ms)

16. Patients who are currently, or have recently (within 3 months) been enrolled in another CTIMP.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Imperial College Hammersmith campus

London, , United Kingdom

Countries

United Kingdom

References

Spriggs MJ, Douglass HM, Park RJ, Read T, Danby JL, de Magalhaes FJC, Alderton KL, Williams TM, Blemings A, Lafrance A, Nicholls DE, Erritzoe D, Nutt DJ, Carhart-Harris RL. Study Protocol for "Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study". Front Psychiatry. 2021 Oct 20;12:735523. doi: 10.3389/fpsyt.2021.735523. eCollection 2021.

Reference Type: DERIVED

PMID: 34744825 (View on PubMed)

Other Identifiers

19HH5267

Identifier Type: -

Identifier Source: org_study_id