Clinical trial NCT05685407: Examining Caffeine as a Treatment for Antidepressant-induced Arousal Dysfunction in Women
Official title: Examining Caffeine as a Treatment for Antidepressant-induced Arousal Dysfunction in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Female Sexual Arousal Disorder
Keywords: female sexual dysfunction
female sexual arousal disorder
caffeine
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Vaginal pulse amplitude via vaginal photoplethysmography
timeFrame: 15 minutes post-ingestion of caffeine and placebo
Secondary outcomes:
measure: Subjective sexual arousal via Heiman and Rowland's (1983) Film Scale
timeFrame: 30 minutes post-ingestion of caffeine and placebo
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin, Sexual Psychophysiology Laboratory
state: Texas
Study officials:
affiliation: The University of Texas at Austin
name: Cindy M Meston, PhD
role: PRINCIPAL_INVESTIGATOR
References: