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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caffeine | Experimental | During one of two counterbalanced experimental sessions, participants will ingest 300mg of caffeine orally via capsules. |
|
| Placebo | Placebo Comparator | During one of two counterbalanced experimental sessions, participants will ingest placebo orally via capsules. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caffeine | Drug | 300mg caffeine will be administered orally via capsules to participants with female sexual arousal disorder. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cindy M Meston, PhD | The University of Texas at Austin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas at Austin, Sexual Psychophysiology Laboratory | Austin | Texas | 78712 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Nov 28, 2022 | Jan 5, 2023 | Prot_ICF_000.pdf |
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| ID | Term |
|---|---|
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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| Placebo | Other | A placebo pill that matches in size, shape, and color will be administered to participants with female sexual arousal disorder. |
|
| 30 minutes post-ingestion of caffeine and placebo |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |