- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07271030
The Use of Cannabidiol Suppositories for Sexual Pain
The Use of Cannabidiol Suppositories for Sexual Pain: A Randomised Controlled Study
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.
Study Overview
Status
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anna Kamyk
- Phone Number: 02074230000
- Email: rpo@londonmet.ac.uk
Study Locations
-
-
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London, United Kingdom, N7 8DB
- Recruiting
- School of Social Sciences and Professions
-
Contact:
- Samantha Banbury, PhD
- Email: s.banbury1@londonmet.ac.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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 dose specific 30mg
|
|
Experimental: 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 dose specific 50mg
|
|
Experimental: 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 dose specific 100mg
|
|
Active Comparator: 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.
|
Care as usual group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Female Sexual Function Index
Time Frame: 0, 4 and 12 weeks
|
This is a 19 item measure of sexual pain, sexual desire, orgasm, lubrication, and sexual satisfaction with five response categories.
The score range is 2.0 to 36.0 with 26.0 being the cut of for sexual dysfunction.
Example questions include, Over the past 4 weeks, how often did you experience discomfort or pain during vaginal penetration?
and Over the past 4 weeks, how would you rate your level of discomfort or pain during or following vaginal penetration?
Cronbach alpha for this questionnaire is .820
and higher.
|
0, 4 and 12 weeks
|
|
The Short Warwick Edinburgh Mental Well-being Scale
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 for the questionnaire is 0.89-0.91.
There is no reverse scoring.
Scores range from 7 to 35 where the latter is the highest level of wellbeing.
|
0, 4 and 12 weeks
|
|
Brief Quality of Life Scale
Time Frame: Weeks 0, 4 and 12
|
An 8 item questionnaire with five response categories looking at satisfaction with self, friends, family and creativity.
This scale is scored by transforming the individual item scores from a 1 to 5 scale to a 0 to 100 scale.
Example responses include how I view my life as necessary for my quality of life, and I am satisfied with my friends and friendship: The Cronbach alpha is .760
for this questionnaire
|
Weeks 0, 4 and 12
|
|
Changes in levels of anal pain taken
Time Frame: Weeks 0, 4 and 12
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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.
|
Weeks 0, 4 and 12
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Samantha Banbury, London Metropolitan University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- Boardman LA, Stockdale CK. Sexual pain. Clin Obstet Gynecol. 2009 Dec;52(4):682-90. doi: 10.1097/GRF.0b013e3181bf4a7e.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LondonsMUSB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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