The Use of Cannabidiol Suppositories for Sexual Pain

NCT07271030 | Recruiting DMC

• 1 other identifier: LondonsMUSB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Research aim: To determine how cannabidiol suppositories might reduce sexual pain during intimacy. Outcomes are also hoped to increase sexual functioning, well-being, and quality of life. Research intention: If cannabidiol suppository intervention reduces sexual pain and increases general well-being, then this research would be repeated on a larger scale, targeting psychosexual services. A brief overview of the intervention: Quantitatively, randomisation of cannabidiol suppositories will be into dose-specific groups. The intervention will be delivered over a period of one month, with follow-up scheduled at 12 weeks. Qualitatively, participants were asked approximately eight open-ended feedback questions throughout the study.

Conditions

Well-Being, Psychological; Quality of Life; Sexual Behavior; Sexual Pain Disorder

Outcome Measures

Primary Outcomes (4)

• The Female Sexual Function Index

  This is a 19 item measure of sexual pain, sexual desire, orgasm, lubrication, and sexual satisfaction with five response categories. The score range is 2.0 to 36.0 with 26.0 being the cut of for sexual dysfunction. Example questions include, Over the past 4 weeks, how often did you experience discomfort or pain during vaginal penetration? and Over the past 4 weeks, how would you rate your level of discomfort or pain during or following vaginal penetration? Cronbach alpha for this questionnaire is .820 and higher.

  0, 4 and 12 weeks

• The Short Warwick Edinburgh Mental Well-being Scale

  This is a 7 item questionnaire with 5 response categories looking at functioning and feeling aspects of well-being. The response categories include 1=none of the time to 5=all of the time. Cronbach alpha for the questionnaire is 0.89-0.91. There is no reverse scoring. Scores range from 7 to 35 where the latter is the highest level of wellbeing.

  0, 4 and 12 weeks

• Brief Quality of Life Scale

  An 8 item questionnaire with five response categories looking at satisfaction with self, friends, family and creativity. This scale is scored by transforming the individual item scores from a 1 to 5 scale to a 0 to 100 scale. Example responses include how I view my life as necessary for my quality of life, and I am satisfied with my friends and friendship: The Cronbach alpha is .760 for this questionnaire

  Weeks 0, 4 and 12

• Changes in levels of anal pain taken

  The frequency and severity of pain during anal sex, this is a 5-point Likert-type scale which ranges from never (5) to all the time (1) and no anal pain (5) to severe anal pain (1). The Cronbach alpha in this study= 0.70.

  Weeks 0, 4 and 12

Study Arms (4)

Cannabidiol 30mg

EXPERIMENTAL

This will be a dose specific suppository of 30mg, which will be used for one month. Frequency will depend on how often the participant engages in sexual intimacy.

Dietary Supplement: Cannabidiol suppository intervention 1

Cannabidiol 50mg

EXPERIMENTAL

This will be a dose specific suppository of 50mg, which will be used for one month. Frequency will depend on how often the participant engages in sexual intimacy.

Dietary Supplement: Cannabidiol suppository intervention 2

Cannabidiol 100mg

EXPERIMENTAL

This will be a dose specific suppository of 100mg, which will be used for one month. Frequency will depend on how often the participant engages in sexual intimacy.

Dietary Supplement: Cannabidiol suppository intervention 3

Care as usual

ACTIVE COMPARATOR

This is the care as usual group, which will be the control for comparative outcomes with sexual function, sexual pain, well being and quality of life.

Other: Non cannabidiol group control

Interventions

Cannabidiol suppository intervention 1 DIETARY_SUPPLEMENT

Cannabidiol suppository dose specific 30mg

Cannabidiol 30mg

Cannabidiol suppository intervention 2 DIETARY_SUPPLEMENT

Cannabidiol suppository dose specific 50mg

Cannabidiol 50mg

Cannabidiol suppository intervention 3 DIETARY_SUPPLEMENT

Cannabidiol suppository dose specific 100mg

Cannabidiol 100mg

Non cannabidiol group control OTHER

Care as usual group

Care as usual

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has previously used cannabidiol in any capacity and has not experienced any allergic reaction
• Is experiencing sexual pain
• There will be an absence of co occurring difficulties
• Has attempted sexual intercourse in the last month
• Age 18 years or older
• Read and write English
• Patient Health Questionnaire 9 screening score range between 0-9 mild
• General Anxiety Disorder 7 screening score range between 0-9 mild
• There are no restrictions on sex, gender, sexuality, or disability

You may not qualify if:

• Has experienced an allergic reaction to cannabidiol in any capacity
• Has not attempted sexual intercourse in the last month
• Has co occurring difficulties
• Aged below 18 years old
• Are not experiencing sexual pain
• Patient Health Questionnaire 9 screening score range between moderate to severe - 10-27
• General Anxiety Disorder 7 screening score range between 10- 21.

Sponsors & Collaborators

• London Metropolitan University: lead

Study Sites (1)

School of Social Sciences and Professions

London, N7 8DB, United Kingdom

RECRUITING

Related Publications (11)

• Mitchell KR, Geary R, Graham CA, Datta J, Wellings K, Sonnenberg P, Field N, Nunns D, Bancroft J, Jones KG, Johnson AM, Mercer CH. Painful sex (dyspareunia) in women: prevalence and associated factors in a British population probability survey. BJOG. 2017 Oct;124(11):1689-1697. doi: 10.1111/1471-0528.14518. Epub 2017 Jan 25.

  PMID: 28120373 RESULT

• Nimbi FM, Rossi V, Tripodi F, Luria M, Flinchum M, Tambelli R, Simonelli C. Genital Pain and Sexual Functioning: Effects on Sexual Experience, Psychological Health, and Quality of Life. J Sex Med. 2020 Apr;17(4):771-783. doi: 10.1016/j.jsxm.2020.01.014. Epub 2020 Feb 13.

  PMID: 32063471 RESULT

• Lo LA, Christiansen AL, Strickland JC, Pistawka CA, Eadie L, Vandrey R, MacCallum CA. Does acute cannabidiol (CBD) use impair performance? A meta-analysis and comparison with placebo and delta-9-tetrahydrocannabinol (THC). Neuropsychopharmacology. 2024 Aug;49(9):1425-1436. doi: 10.1038/s41386-024-01847-w. Epub 2024 Mar 25.

  PMID: 38528133 RESULT

• Boardman LA, Stockdale CK. Sexual pain. Clin Obstet Gynecol. 2009 Dec;52(4):682-90. doi: 10.1097/GRF.0b013e3181bf4a7e.

  PMID: 20393420 RESULT

• Damon W, Rosser BR. Anodyspareunia in men who have sex with men: prevalence, predictors, consequences and the development of DSM diagnostic criteria. J Sex Marital Ther. 2005 Mar-Apr;31(2):129-41. doi: 10.1080/00926230590477989.

  PMID: 15859372 RESULT

• Haroutounian S, Ratz Y, Ginosar Y, Furmanov K, Saifi F, Meidan R, Davidson E. The Effect of Medicinal Cannabis on Pain and Quality-of-Life Outcomes in Chronic Pain: A Prospective Open-label Study. Clin J Pain. 2016 Dec;32(12):1036-1043. doi: 10.1097/AJP.0000000000000364.

  PMID: 26889611 RESULT

• Rosser BR, Short BJ, Thurmes PJ, Coleman E. Anodyspareunia, the unacknowledged sexual dysfunction: a validation study of painful receptive anal intercourse and its psychosexual concomitants in homosexual men. J Sex Marital Ther. 1998 Oct-Dec;24(4):281-92. doi: 10.1080/00926239808403963.

  PMID: 9805288 RESULT

• Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.

  PMID: 10782451 RESULT

• Banbury S, Tharmalingam H, Lusher J, Erridge S, Chandler C. A Preliminary Investigation into the Use of Cannabis Suppositories and Online Mindful Compassion for Improving Sexual Function Among Women Following Gynaecological Cancer Treatment. Medicina (Kaunas). 2024 Dec 7;60(12):2020. doi: 10.3390/medicina60122020.

  PMID: 39768900 RESULT

• Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.

  PMID: 18042300 RESULT

• Lindner P, Frykheden O, Forsstrom D, Andersson E, Ljotsson B, Hedman E, Andersson G, Carlbring P. The Brunnsviken Brief Quality of Life Scale (BBQ): Development and Psychometric Evaluation. Cogn Behav Ther. 2016 Apr;45(3):182-95. doi: 10.1080/16506073.2016.1143526. Epub 2016 Feb 17.

  PMID: 26886248 RESULT

MeSH Terms

Conditions

Psychological Well-Being; Sexual Behavior

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Samantha Banbury

  London Metropolitan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Kamyk

CONTACT

02074230000; rpo@londonmet.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study phase is not applicable, as cannabidiol suppositories are not considered a drug. Randomisation would be based on dose specific groups, including, for example, 30, 50, 100mg and care as usual group.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: January 16, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)