Pain;Sexual Intercourse;MNCT06435650
The Use of Mindful Compassion and Cannabis Suppositories for Anal Pain Among Men Who Have Sex With Men
A study testing Cannabis suppositories and mindful-compassion for anal pain and Mindful-compassion in people with Pain;Sexual Intercourse;M, run by London Metropolitan University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain;Sexual Intercourse;M
- What is being tested?
- Cannabis suppositories and mindful-compassion for anal pain and Mindful-compassion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2023to 24 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
Research looking at mindfulness-based interventions or the use of medical cannabis to support sexual pain is limited, and often, sexual pain goes unreported, which might lead to compromised psychological well-being. Additionally, sexual problems associated with pain and related emotional suffering are frequently overlooked in patients with sexual pain. This research aims to establish the effectiveness of an online mindful compassion intervention adjunct with cannabis suppositories to help minimise sexual pain and increase well-being. This research decided to deliver mindful compassion online because it would economically target a more comprehensive and diverse group. This preliminary study examined how a mindful compassion intervention combined with cannabis suppositories might help minimise sexual pain whilst improving sexual function, well-being, and sexual self-efficacy.
The main exercises included mindfulness, breathing, relaxation techniques, Mindfulness of the senses and body, and understanding the self. These exercises incorporated the three-model system of emotions, how to attend to the cognitive and physical patterns associated with painful sex, and towards acceptance and self-compassion with fewer symptoms. The mindful-compassion intervention included psychosexual education and anal pain, the three-model system of emotions and sexual pain, practising mindful compassion and graded practice and self-care, efficacy, and the relationship with anatomy.
Homework exercises, including education, training, modelling, and enablement, were encouraged. Feedback and support, along with discussing the educational components, training, modelling, and enablement, were addressed throughout this study.
The development of mindful compassion intervention has been based on a taxonomy of behavioural change techniques. This has been used because the taxonomy of behavioural change techniques has been rigorously tested to evidence the effectiveness in supporting interventions associated with change behaviour. The 93 behaviour change techniques are the active ingredients of behaviour change, and each intervention is likely to consist of more than one behaviour change technique and serve as having more than one function. The intervention in this study included twelve domains, of which twenty-three out of the 93 behaviour change techniques listed in the behavioural change technique taxonomy were identified. The selection of these domains used a triangulation process to ensure consistency in mapping the behaviour change techniques to the intervention.
Randomisation was based on whether participants were already using cannabis suppositories or not. Those who did use cannabis suppositories as part of their sex life would have been doing so for at least a month. There was a total of four groups, including a cannabis suppository-only group, a mindful-compassion-only group, a combined mindful compassion and cannabis suppository group and a care-as-usual group.
- Conditions
- Pain;Sexual Intercourse;M
- Being tested
- Cannabis suppositories and mindful-compassion for anal pain, Mindful-compassion
- Keywords
- Mindful-compassion, Well-being, Sexual self efficacy, Sexual functioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis suppositories and mindful-compassion for anal painCombination product
This is a combined intervention that includes mindful-compassion and cannabis suppositories for anal pain
Mindful-compassionBehavioural
Mindful-compassion
| Study group | Role | What they receive |
|---|---|---|
| Mindful-compassion group | Experimental | Online mindful-compassion weekly for four weeks Receives: 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 Receives: Combination Product: Cannabis suppositories and mindful-compassion for anal pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0, 4 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Jul 2023
- Primary completion1 Dec 2023
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Pain;Sexual Intercourse;MStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samantha Banbury, London Metropolitan University
- Investigators
- Samantha Banbury, Principal investigator, London Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435650
- Sponsor's protocol ID
- London Metropolitan University
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barach E, Slavin MN, Earleywine M. Cannabis and Vulvodynia Symptoms: A Preliminary Report. Cannabis. 2020 Jul 3;3(2):139-147. doi: 10.26828/cannabis.2020.02.001.
PubMed 33426502Bloomfield MA, Ashok AH, Volkow ND, Howes OD. The effects of Delta9-tetrahydrocannabinol on the dopamine system. Nature. 2016 Nov 17;539(7629):369-377. doi: 10.1038/nature20153.
PubMed 27853201Boardman LA, Stockdale CK. Sexual pain. Clin Obstet Gynecol. 2009 Dec;52(4):682-90. doi: 10.1097/GRF.0b013e3181bf4a7e.
PubMed 20393420Brenneisen R, Egli A, Elsohly MA, Henn V, Spiess Y. The effect of orally and rectally administered delta 9-tetrahydrocannabinol on spasticity: a pilot study with 2 patients. Int J Clin Pharmacol Ther. 1996 Oct;34(10):446-52.
PubMed 8897084Brotto LA, Bergeron S, Zdaniuk B, Driscoll M, Grabovac A, Sadownik LA, Smith KB, Basson R. A Comparison of Mindfulness-Based Cognitive Therapy Vs Cognitive Behavioral Therapy for the Treatment of Provoked Vestibulodynia in a Hospital Clinic Setting. J Sex Med. 2019 Jun;16(6):909-923. doi: 10.1016/j.jsxm.2019.04.002. Epub 2019 May 15.
PubMed 31103481Carey RN, Connell LE, Johnston M, Rothman AJ, de Bruin M, Kelly MP, Michie S. Behavior Change Techniques and Their Mechanisms of Action: A Synthesis of Links Described in Published Intervention Literature. Ann Behav Med. 2019 Jul 17;53(8):693-707. doi: 10.1093/abm/kay078.
PubMed 30304386ElSohly MA, Gul W, Walker LA. Pharmacokinetics and Tolerability of Delta9-THC-Hemisuccinate in a Suppository Formulation as an Alternative to Capsules for the Systemic Delivery of Delta9-THC. Med Cannabis Cannabinoids. 2018 Jun 12;1(1):44-53. doi: 10.1159/000489037. eCollection 2018 Jun.
PubMed 34676321Fisher E, Moore RA, Fogarty AE, Finn DP, Finnerup NB, Gilron I, Haroutounian S, Krane E, Rice ASC, Rowbotham M, Wallace M, Eccleston C. Cannabinoids, cannabis, and cannabis-based medicine for pain management: a systematic review of randomised controlled trials. Pain. 2021 Jul 1;162(Suppl 1):S45-S66. doi: 10.1097/j.pain.0000000000001929.
PubMed 32804836Kondrad E. Medical marijuana for chronic pain. N C Med J. 2013 May-Jun;74(3):210-1. No abstract available.
PubMed 23940889Liang AL, Gingher EL, Coleman JS. Medical Cannabis for Gynecologic Pain Conditions: A Systematic Review. Obstet Gynecol. 2022 Feb 1;139(2):287-296. doi: 10.1097/AOG.0000000000004656.
PubMed 35104069Libman E, Rothenberg I, Fichten CS, Amsel R. The SSES-E: a measure of sexual self-efficacy in erectile functioning. J Sex Marital Ther. 1985 Winter;11(4):233-47. doi: 10.1080/00926238508405450.
PubMed 4078907Vaishnava PP, Kimball CW, Matykiewicz JL, Fradin FY, Shenoy GK, Montano PA. Extended x-ray-absorption fine-structure observation of collinear ordering of Fe-Sn-Fe atoms in the Chevrel-phase superconductor SnFe0.05Mo6S8. Phys Rev B Condens Matter. 1986 Oct 1;34(7):4599-4603. doi: 10.1103/physrevb.34.4599. No abstract available.
PubMed 9940251Haug T. Tolerance to the depressant effects of diazepam in the drug discrimination paradigm. Pharmacol Biochem Behav. 1984 Sep;21(3):409-15. doi: 10.1016/s0091-3057(84)80103-3.
PubMed 6494210Nercessian TR, Banbury S, Chandler C. A Systematic Review Looking at Anodyspareunia Among Cisgender Men and Women. J Sex Marital Ther. 2023;49(7):829-841. doi: 10.1080/0092623X.2023.2196265. Epub 2023 Apr 23.
PubMed 37089031Suarez Guglielmini H, Schurmann Ruppert R, O'Ryan Costa P. [Measles. Clinical and anatomo-pathologic study]. Rev Chil Pediatr. 1966 Aug-Sep;37(8):477-84. No abstract available. Spanish.
PubMed 5986896
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Mindful Compassion and Cannabis Suppositories for Anal Pain Among Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT06435650
- Acronym / sponsor ID
- London Metropolitan University
- Conditions
- Pain;Sexual Intercourse;M
- Keywords
- Mindful-compassion, Well-being, Sexual self efficacy, Sexual functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- London Metropolitan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Research looking at mindfulness-based interventions or the use of medical cannabis to support sexual pain is limited, and often, sexual pain goes unreported, which might lead to compromised psychological well-being. Additionally, sexual problems associated with pain and related emotional suffering are frequently overlooked in patients with sexual pain. This research aims to establish the effectiveness of an online mindful compassion intervention adjunct with cannabis suppositories to help minimise sexual pain and increase well-being. This research decided to deliver mindful compassion online because it would economically target a more comprehensive and diverse group. This preliminary study examined how a mindful compassion intervention combined with cannabis suppositories might help minimise sexual pain whilst improving sexual function, well-being, and sexual self-efficacy.
The main exercises included mindfulness, breathing, relaxation techniques, Mindfulness of the senses and body, and understanding the self. These exercises incorporated the three-model system of emotions, how to attend to the cognitive and physical patterns associated with painful sex, and towards acceptance and self-compassion with fewer symptoms. The mindful-compassion intervention included psychosexual education and anal pain, the three-model system of emotions and sexual pain, practising mindful compassion and graded practice and self-care, efficacy, and the relationship with anatomy.
Homework exercises, including education, training, modelling, and enablement, were encouraged. Feedback and support, along with discussing the educational components, training, modelling, and enablement, were addressed throughout this study.
The development of mindful compassion intervention has been based on a taxonomy of behavioural change techniques. This has been used because the taxonomy of behavioural change techniques has been rigorously tested to evidence the effectiveness in supporting interventions associated with change behaviour. The 93 behaviour change techniques are the active ingredients of behaviour change, and each intervention is likely to consist of more than one behaviour change technique and serve as having more than one function. The intervention in this study included twelve domains, of which twenty-three out of the 93 behaviour change techniques listed in the behavioural change technique taxonomy were identified. The selection of these domains used a triangulation process to ensure consistency in mapping the behaviour change techniques to the intervention.
Randomisation was based on whether participants were already using cannabis suppositories or not. Those who did use cannabis suppositories as part of their sex life would have been doing so for at least a month. There was a total of four groups, including a cannabis suppository-only group, a mindful-compassion-only group, a combined mindful compassion and cannabis suppository group and a care-as-usual group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Mindful-compassion group | Experimental | Behavioral: Mindful-compassionOnline mindful-compassion weekly for four weeks |
| Mindful-compassion and Cannabis suppository | Experimental | Combination Product: Cannabis suppositories and mindful-compassion for anal painParticipants 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabis suppositories and mindful-compassion for anal painThis is a combined intervention that includes mindful-compassion and cannabis suppositories for anal pain | Combination product | Mindful-compassion and Cannabis suppository |
| Mindful-compassionMindful-compassion | Behavioural | Mindful-compassion group |
Primary outcome
Changes in levels of anal pain taken at weeks 0, 4 and 12
Time frame: 0, 4 and 12 weeks
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.
Changes in sexual functioning taken at weeks 0, 4 and 12
Time frame: 0, 4 and 12 weeks
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.
Changes in levels of well-being at weeks 0,4 and 12
Time frame: 0, 4 and 12 weeks
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.
Changes in levels of sexual self-efficacy at weeks 0, 4 and 12
Time frame: 0, 4 and 12 weeks
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.
Changes in levels of mindful-compassion
Time frame: 0, 4 and 12
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Results publication: PubMed 33426502Barach E, Slavin MN, Earleywine M. Cannabis and Vulvodynia Symptoms: A Preliminary Report. Cannabis. 2020 Jul 3;3(2):139-147. doi: 10.26828/cannabis.2020.02.001.
- Results publication: PubMed 27853201Bloomfield MA, Ashok AH, Volkow ND, Howes OD. The effects of Delta9-tetrahydrocannabinol on the dopamine system. Nature. 2016 Nov 17;539(7629):369-377. doi: 10.1038/nature20153.
- Results publication: PubMed 20393420Boardman LA, Stockdale CK. Sexual pain. Clin Obstet Gynecol. 2009 Dec;52(4):682-90. doi: 10.1097/GRF.0b013e3181bf4a7e.
- Results publication: PubMed 8897084Brenneisen R, Egli A, Elsohly MA, Henn V, Spiess Y. The effect of orally and rectally administered delta 9-tetrahydrocannabinol on spasticity: a pilot study with 2 patients. Int J Clin Pharmacol Ther. 1996 Oct;34(10):446-52.
- Results publication: PubMed 31103481Brotto LA, Bergeron S, Zdaniuk B, Driscoll M, Grabovac A, Sadownik LA, Smith KB, Basson R. A Comparison of Mindfulness-Based Cognitive Therapy Vs Cognitive Behavioral Therapy for the Treatment of Provoked Vestibulodynia in a Hospital Clinic Setting. J Sex Med. 2019 Jun;16(6):909-923. doi: 10.1016/j.jsxm.2019.04.002. Epub 2019 May 15.
- Results publication: PubMed 30304386Carey RN, Connell LE, Johnston M, Rothman AJ, de Bruin M, Kelly MP, Michie S. Behavior Change Techniques and Their Mechanisms of Action: A Synthesis of Links Described in Published Intervention Literature. Ann Behav Med. 2019 Jul 17;53(8):693-707. doi: 10.1093/abm/kay078.
- Results publication: PubMed 34676321ElSohly MA, Gul W, Walker LA. Pharmacokinetics and Tolerability of Delta9-THC-Hemisuccinate in a Suppository Formulation as an Alternative to Capsules for the Systemic Delivery of Delta9-THC. Med Cannabis Cannabinoids. 2018 Jun 12;1(1):44-53. doi: 10.1159/000489037. eCollection 2018 Jun.
- Results publication: PubMed 32804836Fisher E, Moore RA, Fogarty AE, Finn DP, Finnerup NB, Gilron I, Haroutounian S, Krane E, Rice ASC, Rowbotham M, Wallace M, Eccleston C. Cannabinoids, cannabis, and cannabis-based medicine for pain management: a systematic review of randomised controlled trials. Pain. 2021 Jul 1;162(Suppl 1):S45-S66. doi: 10.1097/j.pain.0000000000001929.
- Results publication: PubMed 23940889Kondrad E. Medical marijuana for chronic pain. N C Med J. 2013 May-Jun;74(3):210-1. No abstract available.
- Results publication: PubMed 35104069Liang AL, Gingher EL, Coleman JS. Medical Cannabis for Gynecologic Pain Conditions: A Systematic Review. Obstet Gynecol. 2022 Feb 1;139(2):287-296. doi: 10.1097/AOG.0000000000004656.
- Results publication: PubMed 4078907Libman E, Rothenberg I, Fichten CS, Amsel R. The SSES-E: a measure of sexual self-efficacy in erectile functioning. J Sex Marital Ther. 1985 Winter;11(4):233-47. doi: 10.1080/00926238508405450.
- Results publication: PubMed 9940251Vaishnava PP, Kimball CW, Matykiewicz JL, Fradin FY, Shenoy GK, Montano PA. Extended x-ray-absorption fine-structure observation of collinear ordering of Fe-Sn-Fe atoms in the Chevrel-phase superconductor SnFe0.05Mo6S8. Phys Rev B Condens Matter. 1986 Oct 1;34(7):4599-4603. doi: 10.1103/physrevb.34.4599. No abstract available.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samantha Banbury principal investigator
London Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cannabis suppositories and mindful-compassion for anal pain and Mindful-compassion in people with Pain;Sexual Intercourse;M, run by London Metropolitan University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in levels of anal pain taken at weeks 0, 4 and 12 (time frame: 0, 4 and 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06435650, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.