The Use of Cannabidiol Suppositories for Sexual Pain: A Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The Female Sexual Function Index
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Cannabidiol suppository intervention 1 (Dietary Supplement)
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.
干预措施: Cannabidiol suppository intervention 2 (Dietary Supplement)
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.
干预措施: Cannabidiol suppository intervention 3 (Dietary Supplement)
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.
干预措施: Non cannabidiol group control (Other)
结局指标
主要结局
The Female Sexual Function Index
时间窗: 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
时间窗: 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
时间窗: 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
Changes in levels of anal pain taken
时间窗: 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.
次要结局
未报告次要终点