Skip to main content
OpenTrials
Completed

NCT Number: NCT05685407

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Female Sexual Arousal Disorder

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

The University of Texas at Austin, Sexual Psychophysiology Laboratory

Austin, Texas, 78712, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caffeine

Drug

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

Placebo

Other

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

Primary outcomes

  1. Vaginal pulse amplitude via vaginal photoplethysmography

    Time frame: 15 minutes post-ingestion of caffeine and placebo

    Vaginal pulse amplitude reflects phasic changes in vaginal engorgement with each heart beat, where higher amplitudes indicate higher levels of blood flow

Secondary outcomes

  1. Subjective sexual arousal via Heiman and Rowland's (1983) Film Scale

    Time frame: 30 minutes post-ingestion of caffeine and placebo

    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.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 17, 2023
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.