Quality of Life, Sexual Behavior, Sexual Pain Disorder, Well-Being, Psychological
Conditions
Brief summary
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.
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.
Interventions
DIETARY_SUPPLEMENTCannabidiol suppository intervention 1
Cannabidiol suppository dose specific 30mg
DIETARY_SUPPLEMENTCannabidiol suppository intervention 2
Cannabidiol suppository dose specific 50mg
DIETARY_SUPPLEMENTCannabidiol suppository intervention 3
Cannabidiol suppository dose specific 100mg
OTHERNon cannabidiol group control
Care as usual group
Sponsors
London Metropolitan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study phase is not applicable, as cannabidiol suppositories are not considered a drug. Randomisation would be based on dose specific groups, including, for example, 30, 50, 100mg and care as usual group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in levels of anal pain taken | 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. |
| The Female Sexual Function Index | 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. |
| The Short Warwick Edinburgh Mental Well-being Scale | 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. |
| Brief Quality of Life Scale | 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 |
Countries
United Kingdom
Contacts
CONTACTAnna Kamyk
PRINCIPAL_INVESTIGATORSamantha Banbury
London Metropolitan University
Outcome results
None listed