Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2025-12-31
2026-08-31
Brief Summary
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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.
Detailed Description
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Cannabidiol is one of approximately 100 cannabinoids found in cannabis, alongside tetrahydrocannabinol. Cannabidiol is non-intoxicating and regarded as a safe product to use. Cannabidiol has many applications, including in sexual health. Two studies have examined cannabidiol suppositories for supporting sexual function and reducing sexual pain. In both studies, outcomes suggested the pain relieving qualities of cannabidiol oil for both men and women.
This research aims to establish the effectiveness of varied doses of cannabidiol oil to minimise sexual pain and increase well-being. This research is a preliminary study looking at how cannabidiol suppositories aim to reduce pain and support sexual function, wellbeing and quality of life among those experiencing sexual discomfort or pain during intercourse or masturbation.
There will be four groups, where cannabidiol will be randomised to dose-specific groups, approximately 30, 50, and 100mg, under the guidance of a medical practitioner. There will also be a care as usual group.
It is hypothesised that:
Higher levels of sexual functioning, quality of life and wellbeing with lower levels of sexual pain will be reported among those using cannabidiol suppositories at the follow-up after intervention compared to care as usual group.
It is further hypothesised that higher doses of cannabidiol suppositories will have higher levels of sexual pain-reducing outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Randomisation would be based on dose specific groups, including, for example, 30, 50, 100mg and care as usual group.
TREATMENT
NONE
Study Groups
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Cannabidiol 30mg
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.
Cannabidiol suppository intervention 1
Cannabidiol suppository dose specific 30mg
Cannabidiol 50mg
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.
Cannabidiol suppository intervention 2
Cannabidiol suppository dose specific 50mg
Cannabidiol 100mg
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.
Cannabidiol suppository intervention 3
Cannabidiol suppository dose specific 100mg
Care as usual
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.
Non cannabidiol group control
Care as usual group
Interventions
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Cannabidiol suppository intervention 1
Cannabidiol suppository dose specific 30mg
Cannabidiol suppository intervention 2
Cannabidiol suppository dose specific 50mg
Cannabidiol suppository intervention 3
Cannabidiol suppository dose specific 100mg
Non cannabidiol group control
Care as usual group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
100 Years
ALL
Yes
Sponsors
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London Metropolitan University
OTHER
Responsible Party
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Principal Investigators
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Samantha Banbury
Role: PRINCIPAL_INVESTIGATOR
London Metropolitan University
Central Contacts
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References
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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.
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.
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.
Boardman LA, Stockdale CK. Sexual pain. Clin Obstet Gynecol. 2009 Dec;52(4):682-90. doi: 10.1097/GRF.0b013e3181bf4a7e.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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LondonsMUSB
Identifier Type: -
Identifier Source: org_study_id