The Use of Cannabidiol Suppositories for Sexual Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorLondon Metropolitan University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Has not attempted sexual intercourse in the last month
Has co occurring difficulties
Aged below 18 years old
Are not experiencing sexual pain
Trial design
Design model
Parallel
Treatments tested in this trial
Cannabidiol suppository intervention 1
Dietary supplementCannabidiol suppository dose specific 30mg
Cannabidiol suppository intervention 2
Dietary supplementCannabidiol suppository dose specific 50mg
Cannabidiol suppository intervention 3
Dietary supplementCannabidiol suppository dose specific 100mg
Non cannabidiol group control
Other interventionCare as usual group
Treatment groups
50 Participants
are divided into 4 treatment groupsGroup A: Cannabidiol 30mgExperimental treatment 1 intervention
Group B: Cannabidiol 50mgExperimental treatment 1 intervention
Group C: Cannabidiol 100mgExperimental treatment 1 intervention
Group D: Care as usualActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The Female Sexual Function Index
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.
Time frame
0, 4 and 12 weeks2
The Short Warwick Edinburgh Mental Well-being Scale
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.
Time frame
0, 4 and 12 weeks3
Brief Quality of Life Scale
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
Time frame
Weeks 0, 4 and 124
Changes in levels of anal pain taken
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.
Time frame
Weeks 0, 4 and 12Sponsors and contacts
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Source ClinicalTrials.gov