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.

Study Overview

• Status: Completed
• Conditions: Female Sexual Arousal Disorder
• Intervention / Treatment: Drug: Caffeine; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Leah N McMahon, BSA; Phone Number: 5122324805; Email: leahmcmahon@utexas.edu
• Study Contact Backup: Name: Cindy M Meston, PhD; Phone Number: 5122324805; Email: mestoncm@utexas.edu

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • The University of Texas at Austin, Sexual Psychophysiology Laboratory
      • Contact: Leah McMahon, BSA; Phone Number: 512-232-4805; Email: leahmcmahon@utexas.edu
      • Sub-Investigator: Leah N McMahon, BSA
      • Principal Investigator: Cindy M Meston, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Caffeine; During one of two counterbalanced experimental sessions, participants will ingest 300mg of caffeine orally via capsules.	Drug: Caffeine; 300mg caffeine will be administered orally via capsules to participants with female sexual arousal disorder.
Placebo Comparator: Placebo; During one of two counterbalanced experimental sessions, participants will ingest placebo orally via capsules.	Other: Placebo; A placebo pill that matches in size, shape, and color will be administered to participants with female sexual arousal disorder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Investigators: Principal Investigator: Cindy M Meston, PhD, The University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): April 15, 2023
• Study Completion (Actual): April 15, 2023

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: caffeine; female sexual dysfunction; female sexual arousal disorder
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: 00002778

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes