The Use of Mindful Compassion and Cannabis Suppositories for Anal Pain Among Men Who Have Sex With Men

NCT06435650 | Completed DMC

• 1 other identifier: London Metropolitan University
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Research aim: To determine how an online mindful-compassion intervention adjunct with cannabis suppositories might reduce anal pain during sexual intimacy among men who have sex with men. Outcomes are also hoped to increase sexual functioning, well-being and sexual self-efficacy. Research intention: If the combined mindful compassion and cannabis suppository intervention reduces anal pain and supports sexual and general well-being, then this research would be repeated on a larger scale targeting psychosexual services. A brief overview of the intervention: Anal pain is pain experienced in the anus during anal penetration with a penis or other objects. Most research on anal pain during sexual intimacy has centred on men who have sex with men. Mindfulness has been anecdotally discussed in reducing symptoms of anal pain in men who have sex with men. A novel approach to pain management includes medical cannabis, which can be cannabidiol, tetrahydrocannabinol or both. Anal suppositories do not create a euphoric high in the same way as oral use, including inhalation. Quantitatively, randomisation will be based on whether participants use cannabis suppositories or not. This study does not randomise to cannabis groups owing to the legalities in the United Kingdom. Participants included fifty-two consenting participants. Of these, thirty-three were using cannabis suppositories. The intervention was delivered for one month, and the follow-up was at twelve weeks. Qualitatively, participants were asked approximately eight open-ended feedback questions throughout the study.

Conditions

Pain;Sexual Intercourse;M

Keywords

Mindful-compassion; Well-being; Sexual self efficacy; Sexual functioning

Outcome Measures

Primary Outcomes (5)

• Changes in levels of anal pain taken at weeks 0, 4 and 12

  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.

  0, 4 and 12 weeks

• Changes in sexual functioning taken at weeks 0, 4 and 12

  This is an 11-item questionnaire which focuses on sexual functioning including sexual desire, arousal and satisfaction and erectile functioning. The response categories include 0= not at all to 5= always or 0= no problem to 5= big problem (this varied pending question). The Cronbach alpha in this study = 0.75.

  0, 4 and 12 weeks

• Changes in levels of well-being at weeks 0,4 and 12

  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- 0.89-0.91. There is no reverse scoring. Scores range from 7 to 35 where the latter is the highest level of wellbeing. The Cronbach alpha in this study = 0.85.

  0, 4 and 12 weeks

• Changes in levels of sexual self-efficacy at weeks 0, 4 and 12

  This is a 10-item questionnaire which focuses on sexual confidence and behaviour. The response categories include: 1 is the lowest level of self-efficacy and 10 is the highest. There are no reverse questions. Cronbach's alpha is α =0.88 (high). This questionnaire has been adapted to reflect the participants in a study looking at sexual self-efficacy and sexual function. Less than 5% of the original questionnaire remains. The Cronbach alpha in this study= 0.83.

  0, 4 and 12 weeks

• Changes in levels of mindful-compassion

  This is a 12-item measure with 5 response categories, 1 = almost never to 5 = almost always, with higher scores indicating higher levels of self-compassion. The questionnaire measures self-kindness vs. self-judgement, common humanity vs. isolation, and mindfulness vs. over-identification with painful thoughts and emotions. Reliability Cronbach's alphas range between 0.68 and 0.78. The Cronbach alpha in this study was 0.73.

  0, 4 and 12

Study Arms (2)

Mindful-compassion group

EXPERIMENTAL

Online mindful-compassion weekly for four weeks

Behavioral: Mindful-compassion

Mindful-compassion and Cannabis suppository

EXPERIMENTAL

Participants were not prescribed cannabis as part of this study. Participants had been for at least one month before participating in the study. Participants used cannabis suppositories each time they engaged in anal intercourse (recipient). The average dose, based on participant reports, was approximately 500mg. Online mindful-compassion weekly for four weeks

Combination Product: Cannabis suppositories and mindful-compassion for anal pain

Interventions

Cannabis suppositories and mindful-compassion for anal pain COMBINATION_PRODUCT

This is a combined intervention that includes mindful-compassion and cannabis suppositories for anal pain

Mindful-compassion and Cannabis suppository

Mindful-compassion BEHAVIORAL

Mindful-compassion

Mindful-compassion group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Men who have sex with men Those who identify as male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants were allocated to cannabis only, and cannabis adjunct groups would already be using cannabis suppositories.
• Must have engaged in anal sex within the last month
• Must be based in the United Kingdom
• Must have experienced anal sexual pain
• An absence of co-occurring difficulties
• Must be aged 18 years or older
• Must be able to read and write English.
• Patient health screening score must range between 0-9 mild
• Generalised anxiety disorder screening score must range between 0-9, mild

You may not qualify if:

• Have not attempted anal intercourse in the last month
• Have co-occurring difficulties
• Aged below 18 years old
• Reading and writing English difficulties
• Not experiencing anal pain during sexual intercourse.
• Patient health screening score ranged between moderate to severe - 10-27
• Generalised anxiety screening score ranged between 10- 21.

Sponsors & Collaborators

• London Metropolitan University: lead

Study Sites (1)

Samantha Banbury

London, N7 8DB, United Kingdom

Location

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Study Officials

• Samantha Banbury

  London Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study phase is not applicable as whilst cannabis suppositories are part of this research study, participants are not randomised into cannabis groups. Participants would already be using cannabis suppositories for at least one month and are used as part of sexual intimacy. Randomisation was based on whether participants were using cannabis suppositories and consisted of one of four groups, including a cannabis suppository-only group, mindful- compassion only group, a combined mindful-compassion and cannabis suppository group and a care-as-usual group

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 30, 2024
• Study Start: July 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: April 24, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)