The Use of Cannabidiol Suppositories for Sexual Pain

London Metropolitan University

Status: Enrolling

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

Treatments: Dietary Supplement: Cannabidiol suppository intervention 1; Dietary Supplement: Cannabidiol suppository intervention 2; Dietary Supplement: Cannabidiol suppository intervention 3; Other: Non cannabidiol group control

Study type: Interventional

Funder types: Other

Identifiers

NCT07271030

LondonsMUSB

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 4 patient groups

Cannabidiol 30mg

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Cannabidiol suppository intervention 1

Cannabidiol 50mg

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Cannabidiol suppository intervention 2

Cannabidiol 100mg

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Cannabidiol suppository intervention 3

Care as usual

Active Comparator group

Description:

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.

Treatment:

Other: Non cannabidiol group control