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

Primary Purpose

Female Sexual Arousal Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Caffeine
Placebo
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Sexual Arousal Disorder focused on measuring female sexual dysfunction, female sexual arousal disorder, caffeine

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas at Austin, Sexual Psychophysiology Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Caffeine

Placebo

Arm Description

During one of two counterbalanced experimental sessions, participants will ingest 300mg of caffeine orally via capsules.

During one of two counterbalanced experimental sessions, participants will ingest placebo orally via capsules.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
January 5, 2023
Last Updated
June 20, 2023
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT05685407
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
April 15, 2023 (Actual)
Study Completion Date
April 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Sexual Arousal Disorder
Keywords
female sexual dysfunction, female sexual arousal disorder, caffeine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caffeine
Arm Type
Experimental
Arm Description
During one of two counterbalanced experimental sessions, participants will ingest 300mg of caffeine orally via capsules.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
During one of two counterbalanced experimental sessions, participants will ingest placebo orally via capsules.
Intervention Type
Drug
Intervention Name(s)
Caffeine
Intervention Description
300mg caffeine will be administered orally via capsules to participants with female sexual arousal disorder.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A placebo pill that matches in size, shape, and color will be administered to participants with female sexual arousal disorder.
Primary Outcome Measure Information:
Title
Vaginal pulse amplitude via vaginal photoplethysmography
Description
Vaginal pulse amplitude reflects phasic changes in vaginal engorgement with each heart beat, where higher amplitudes indicate higher levels of blood flow
Time Frame
15 minutes post-ingestion of caffeine and placebo
Secondary Outcome Measure Information:
Title
Subjective sexual arousal via Heiman and Rowland's (1983) Film Scale
Description
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.
Time Frame
30 minutes post-ingestion of caffeine and placebo

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cindy M Meston, PhD
Organizational Affiliation
The University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas at Austin, Sexual Psychophysiology Laboratory
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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