Examining Caffeine as a Treatment for Antidepressant-induced Arousal Dysfunction in Women

Female Sexual Arousal Disorder Clinical Trial

Official title:

Examining Caffeine as a Treatment for Antidepressant-induced Arousal Dysfunction in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05685407
• Other study ID #: 00002778
• Status: Completed
• Phase: Phase 1
• Start date: January 1, 2023
• Est. completion date: April 15, 2023

Study information

• Verified date: June 2023
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Antidepressants have negative effects on genital arousal function that hinder quality of life and jeopardize medication adherence. Moderate sympathetic nervous system (SNS) activation through exercise has shown promising results for improving antidepressant-induced genital arousal dysfunction. It is feasible that caffeine - an SNS stimulant - could improve antidepressant-induced genital arousal difficulties if ingested prior to sex. The goal of the present pilot study is to examine whether the acute administration of 300mg of caffeine increases genital arousal in women experiencing antidepressant-induced genital arousal difficulties. Women will attend two counterbalanced sessions in which they ingest either 300mg caffeine or placebo. Fifteen minutes after ingestion, they will view an erotic film while their heart rate and genital sexual arousal are measured. Caffeine could serve as a low-cost, widely accessible intervention with minimal side effects if efficacy is shown.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Between the of ages 18-55
• Fluent in English
• Experience antidepressant-induced arousal difficulties
• Experience regular menstrual periods (i.e., not perimenopausal or menopausal)

Exclusion Criteria:

• A history or current diagnosis of panic attacks or panic disorder
• A history or current diagnosis of sexually transmitted disease(s)
• A history of major pelvic surgery that caused nerve damage
• Currently taking beta blockers, antipsychotics, anti-anxiolytics, hormonal contraceptives (unless the participant has been taking it for over 3 months), or any other medical treatment to enhance sexual response
• Other medical conditions or procedures that would preclude the participant's participation in the study (e.g., urinary tract infection, neurological impairment due to diabetes or stroke, or spinal cord damage)
• A history of childhood sexual abuse (CSA) that occurred prior to age 16

Related Conditions & MeSH terms

• Female Sexual Arousal Disorder
• Sexual Dysfunctions, Psychological

Intervention

Drug:
• Caffeine
300mg caffeine will be administered orally via capsules to participants with female sexual arousal disorder.

Other:
• Placebo
A placebo pill that matches in size, shape, and color will be administered to participants with female sexual arousal disorder.

Locations

Country	Name	City	State
United States	The University of Texas at Austin, Sexual Psychophysiology Laboratory	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal pulse amplitude via vaginal photoplethysmography	Vaginal pulse amplitude reflects phasic changes in vaginal engorgement with each heart beat, where higher amplitudes indicate higher levels of blood flow	15 minutes post-ingestion of caffeine and placebo
Secondary	Subjective sexual arousal via Heiman and Rowland's (1983) Film Scale	Discrete measurement of the construct was calculated by summing the scores of the three original subjective sexual arousal items from Heiman and Rowland's (1983) Film Scale, which assesses sexual arousal as well as positive and negative affect in response to an erotic film. These three items include an assessment of overall "sexual arousal," a sense of "mental sexual arousal," and one reverse-scored item on feeling "sexually turned off." On two occasions during the experiment (immediately following the first neutral-erotic film sequence and immediately following the second neutral-erotic film sequence), participants rated the degree to which they experienced each of the three items on a 7-point Likert scale (where higher scores indicate higher subjective sexual arousal), and then the three scores were combined into a single subjective sexual arousal score for each of the two time points.	30 minutes post-ingestion of caffeine and placebo