The Use of Cannabidiol Suppositories for Sexual Pain

Официальное название

The Use of Cannabidiol Suppositories for Sexual Pain: A Randomised Controlled Study

Обзор

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.

Подробное описание

Sexual pain is a constellation of biopsychosocial disorders which affects men, women and their partners.

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.

Вмешательства

• Пищевая добавка Cannabidiol suppository intervention 1
  Cannabidiol suppository dose specific 30mg
• Пищевая добавка Cannabidiol suppository intervention 2
  Cannabidiol suppository dose specific 50mg
• Пищевая добавка Cannabidiol suppository intervention 3
  Cannabidiol suppository dose specific 100mg
• Другое Non cannabidiol group control
  Care as usual group

Первичные конечные точки

• The Female Sexual Function Index [Срок оценки: 0, 4 and 12 weeks]
• The Short Warwick Edinburgh Mental Well-being Scale [Срок оценки: 0, 4 and 12 weeks]
• Brief Quality of Life Scale [Срок оценки: Weeks 0, 4 and 12]
• Changes in levels of anal pain taken [Срок оценки: Weeks 0, 4 and 12]

Критерии участия

Критерии включения

• 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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• School of Social Sciences and Professions — London

Публикации

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• 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
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• 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
• 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

Идентификаторы

NCT: NCT07271030 · LondonsMUSB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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