Using Aromatherapy in Substance Use Disorder

NCT05660434 | Completed Results

• 1 other identifier: 2204562633
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial study is to see if Bergamot, an aroma therapy essential oil, has any effect on comfort, ease, and stress. Participants will be asked to use a bergamot aroma inhaler, which is a small tube about the size of a lipstick container, at least three times a day for one week. Comfort, ease, and stress will be measured with self-report survey at the beginning and at the end of the week. In addition, participants will be asked to complete a daily logbook to record use of the inhaler. The study lasts for one week (7 days). The aims of this study are to explore the effects of Bergamot essential oil on comfort, ease, and stress in adults in a substance use disorder (SUD) treatment program, and to evaluate the feasibility of this type of aroma therapy intervention.

Conditions

Substance Use Disorders

Keywords

social and behavioral; randomized; questionnaires; aroma therapy

Outcome Measures

Primary Outcomes (4)

• Examine Feasibility (Eligible Participant Recruitment)

  Determine feasibility by assessing the number of eligible participants recruited.

  Up to 18 months

• Examine Feasibility (Eligible Participant Enrollment)

  Determine feasibility by assessing how many eligible participants enroll.

  Up to 18 months

• Examine Feasibility (Participant Retention)

  Determine feasibility by assessing count of participants retained.

  Up to 18 months

• Examine Fidelity of the Intervention

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

  Up to 7 days

Secondary Outcomes (4)

• Change in Perceived Comfort Level

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

• Change in Perceived Ease Level

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

• Change in the Depression, Anxiety, and Stress Scale (DASS-21)

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

• Visual Analogue Scale to Assess Daily Perceived Comfort

  7 days

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: Aroma Inhaler with Bergamot essential oil

Control Group

NO INTERVENTION

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.

Interventions

Aroma Inhaler with Bergamot essential oil OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants can be at any level of treatment, including peer recovery coach program at West Virginia University Comprehensive Opioid Addiction Treatment (COAT) program
• All participants must be alert and oriented
• Provide written consent
• Able to read and write English

You may not qualify if:

• Have a medical history of asthma or other serious respiratory disease
• Known allergy to citrus.
• Dislike of Bergamot

Sponsors & Collaborators

• West Virginia University: lead
• West Virginia Nurses Association: collaborator

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Behavior

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Marian Reven, PhD, RN, AHN-BC, CNE, RA
• Organization: West Virginia University

marian.reven@hsc.wvu.edu

304-293-3399

Study Officials

• Marian Reven, PhD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The person enrolling is masked to the assignment. No need to mask for aroma inhaler as participants receive materials through the mail and do not interact with other participants. No sham inhaler is used.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Principle Investigator

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: December 21, 2022
• Study Start: September 5, 2022
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2025-01

Locations

US (1)