Trial Outcomes & Findings for Using Aromatherapy in Substance Use Disorder (NCT NCT05660434)

NCT ID: NCT05660434

Last Updated: 2025-01-09

Results Overview

Determine feasibility by assessing the number of eligible participants recruited.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: Up to 18 months
• Results posted on: 2025-01-09

Participant Flow

Participant milestones

Measure	Intervention Group Adults (\>18 years) who are currently receiving treatment for substance use disorder (SUD) in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus. Aroma Inhaler with Bergamot essential oil: The intervention group will receive an aroma inhaler and logbook to use three times a day for 7 days and complete pre and post surveys for comfort, ease, and stress.	Control Group Adults (\>18 years) who are currently receiving treatment for SUD in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus.
Overall Study STARTED	45	55
Overall Study COMPLETED	43	54
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Intervention Group Adults (\>18 years) who are currently receiving treatment for substance use disorder (SUD) in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus. Aroma Inhaler with Bergamot essential oil: The intervention group will receive an aroma inhaler and logbook to use three times a day for 7 days and complete pre and post surveys for comfort, ease, and stress.	Control Group Adults (\>18 years) who are currently receiving treatment for SUD in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus.
Overall Study Never obtained study materials	2	1

Baseline Characteristics

Using Aromatherapy in Substance Use Disorder

Baseline characteristics by cohort

Measure	Intervention Group n=45 Participants Adults (\>18 years) who are currently receiving treatment for SUD in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus. Aroma Inhaler with Bergamot essential oil: The intervention group will receive an aroma inhaler and logbook to use three times a day for 7 days and complete pre and post surveys for comfort, ease, and stress.	Control Group n=55 Participants Adults (\>18 years) who are currently receiving treatment for SUD in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants	55 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	35 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=5 Participants	52 Participants n=7 Participants	96 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 18 months

Population: The numbers above reflect all patients that were deemed eligible per criteria.

Determine feasibility by assessing the number of eligible participants recruited.

Outcome measures

Measure	Intervention Group n=45 Participants Adults (\>18 years) who are currently receiving treatment for SUD in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus. Aroma Inhaler with Bergamot essential oil: The intervention group will receive an aroma inhaler and logbook to use three times a day for 7 days and complete pre and post surveys for comfort, ease, and stress.	Control Group n=55 Participants Adults (\>18 years) who are currently receiving treatment for SUD in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus.
Examine Feasibility (Eligible Participant Recruitment)	45 Participants	55 Participants

PRIMARY outcome

Timeframe: Up to 18 months

Population: The numbers above reflect all patients that were deemed eligible per criteria.

Determine feasibility by assessing how many eligible participants enroll.

Outcome measures

Measure	Intervention Group n=45 Participants Adults (\>18 years) who are currently receiving treatment for SUD in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus. Aroma Inhaler with Bergamot essential oil: The intervention group will receive an aroma inhaler and logbook to use three times a day for 7 days and complete pre and post surveys for comfort, ease, and stress.	Control Group n=55 Participants Adults (\>18 years) who are currently receiving treatment for SUD in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus.
Examine Feasibility (Eligible Participant Enrollment)	45 Participants	55 Participants

PRIMARY outcome

Timeframe: Up to 18 months

Population: 3 participants never obtained study materials

Determine feasibility by assessing count of participants retained.

Outcome measures

Measure	Intervention Group n=45 Participants Adults (\>18 years) who are currently receiving treatment for SUD in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus. Aroma Inhaler with Bergamot essential oil: The intervention group will receive an aroma inhaler and logbook to use three times a day for 7 days and complete pre and post surveys for comfort, ease, and stress.	Control Group n=55 Participants Adults (\>18 years) who are currently receiving treatment for SUD in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus.
Examine Feasibility (Participant Retention)	43 Participants	54 Participants

PRIMARY outcome

Timeframe: Up to 7 days

Determine fidelity by assessing the count of participants that completed the intervention as directed as shown in the daily logbook.

Outcome measures

Measure	Intervention Group n=45 Participants Adults (\>18 years) who are currently receiving treatment for SUD in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus. Aroma Inhaler with Bergamot essential oil: The intervention group will receive an aroma inhaler and logbook to use three times a day for 7 days and complete pre and post surveys for comfort, ease, and stress.	Control Group n=55 Participants Adults (\>18 years) who are currently receiving treatment for SUD in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus.
Examine Fidelity of the Intervention	45 Participants	55 Participants

SECONDARY outcome

Timeframe: Pre test prior to day 1 to Post test after 1 week

The concept of comfort is operationalized by the Generalized Comfort Questionnaire (GCQ). This incorporates a Likert scale from 1 to 6 with 1 being the least agreement with the statement and 6 being the most agreement with the statement. The investigators are looking at a change in comfort from before the intervention to after the intervention. There were 28 questions in this scale with a total score between 28 and 168. There are 3 subscales of Relief (8 questions) , Ease (10 questions), and Transcendence (10 questions). A higher score post test cumulative or as subscales indicates more agreement with the statements of overall comfort and its subscales.

Outcome measures

Measure	Intervention Group n=45 Participants Adults (\>18 years) who are currently receiving treatment for SUD in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus. Aroma Inhaler with Bergamot essential oil: The intervention group will receive an aroma inhaler and logbook to use three times a day for 7 days and complete pre and post surveys for comfort, ease, and stress.	Control Group n=55 Participants Adults (\>18 years) who are currently receiving treatment for SUD in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus.
Change in Perceived Comfort Level Before Intervention	116.29 score on a scale Standard Deviation 21.798	114.17 score on a scale Standard Deviation 22.050
Change in Perceived Comfort Level After Intervention	117.91 score on a scale Standard Deviation 20.599	114.84 score on a scale Standard Deviation 21.683

SECONDARY outcome

Timeframe: Pre test prior to day 1 to Post test after 1 week

The concept of ease is measured using the Ease measure. This is assessed using a Likert scale from 1 to 4. There is only one score reported for this measure, no subscales. The investigators are looking at a change in ease from before the intervention to after the intervention. There are 20 questions with a range of scores between 20 and 80. The lower score indicates less agreement with the statement about ease. A higher score indicates more agreement. A higher score post test indicates an improvement.

Outcome measures

Measure	Intervention Group n=45 Participants Adults (\>18 years) who are currently receiving treatment for SUD in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus. Aroma Inhaler with Bergamot essential oil: The intervention group will receive an aroma inhaler and logbook to use three times a day for 7 days and complete pre and post surveys for comfort, ease, and stress.	Control Group n=55 Participants Adults (\>18 years) who are currently receiving treatment for SUD in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus.
Change in Perceived Ease Level Before Intervention	53.04 score on a scale Standard Deviation 9.925	53.88 score on a scale Standard Deviation 8.993
Change in Perceived Ease Level After Intervention	57.21 score on a scale Standard Deviation 11.482	55.58 score on a scale Standard Deviation 8.212

SECONDARY outcome

Timeframe: Pre test prior to day 1 to Post test after 1 week

The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.

Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items. This is assessed using a Likert scale from 0 to 3 with 0 being the least amount of stress and 3 being the highest amount of stress. Scores range from 0 to 63 with lower score indicating less agreement with statements and 63 indicating higher score in agreement with statements. A lower score indicates improvement in DASS.

Outcome measures

Measure	Intervention Group n=45 Participants Adults (\>18 years) who are currently receiving treatment for SUD in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus. Aroma Inhaler with Bergamot essential oil: The intervention group will receive an aroma inhaler and logbook to use three times a day for 7 days and complete pre and post surveys for comfort, ease, and stress.	Control Group n=55 Participants Adults (\>18 years) who are currently receiving treatment for SUD in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus.
Change in the Depression, Anxiety, and Stress Scale (DASS-21) Before Intervention	20.49 score on a scale Standard Deviation 11.482	20.28 score on a scale Standard Deviation 10.747
Change in the Depression, Anxiety, and Stress Scale (DASS-21) After Intervention	18.54 score on a scale Standard Deviation 10.404	21.34 score on a scale Standard Deviation 10.953

SECONDARY outcome

Timeframe: 7 days

Population: Per Protocol only 25 participants were included in the Intervention group for this outcome measure.

The Visual Analogue Scale (VAS) is used as a daily measure of comfort. It provides validation for the GCQ using a 100mm line where Comfort is rated using a mark on the line between 0 and 100 "I feel as comfortable as possible" with 0 being the least comfortable and 100 being the most comfortable.

Outcome measures

Measure	Intervention Group n=25 Participants Adults (\>18 years) who are currently receiving treatment for SUD in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus. Aroma Inhaler with Bergamot essential oil: The intervention group will receive an aroma inhaler and logbook to use three times a day for 7 days and complete pre and post surveys for comfort, ease, and stress.	Control Group n=42 Participants Adults (\>18 years) who are currently receiving treatment for SUD in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus.
Visual Analogue Scale to Assess Daily Perceived Comfort Day 1	66.72 score on a scale Standard Deviation 18.729	49.02 score on a scale Standard Deviation 26.386
Visual Analogue Scale to Assess Daily Perceived Comfort Day 7	80.68 score on a scale Standard Deviation 11.707	55.71 score on a scale Standard Deviation 26.516

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Marian Reven, PhD, RN, AHN-BC, CNE, RA

West Virginia University

Phone: 304-293-3399

Email: marian.reven@hsc.wvu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place