Clinical trial NCT04776616: Green Light Therapy As a Non-Pharmacologic Intervention to Decrease Anxiety in Pregnant Women With Opioid Use Disorder
Official title: Green Light Therapy As a Non-Pharmacologic Intervention to Decrease Anxiety in Pregnant Women With Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Pregnancy
Opioid Use Disorder
ACE
STAI
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pilot randomized controlled trial with 1:1 control and intervention
Primary purpose: TREATMENT

Brief summary: This is a clinical trial evaluating anxiety reduction for women with opioid use disorder affecting pregnancy. It is well documented that anxiety increases as pregnancy progresses. The investigators hypothesize that women who undergo green light therapy (experimental arm) will have a smaller increase in anxiety scores compared to the women who undergo white light therapy (control arm).

The investigators will also look at how much opiate replacement therapy increases women require during the study period, and how much opiate they require during admission for delivery. The investigators think this a is a low risk intervention in a pregnant population that has higher levels of anxiety when compared to the general population. The investigators believe based on animal studies that this could be effective, and change the way providers treat and support individuals with substance use disorder.

The opioid epidemic has negatively impacted our society at many levels. Finding non-pharmacologic ways to support patients while in recovery/sustained sobriety that are simple and low cost would be a step forward in providing compassionate and comprehensive treatment to individuals affected by Opioid Use Disorder.

Detailed description: At time of enrollment, participants will be administered a States-Traits Anxiety Inventory (STAI) questionnaire, undergo screening for ACE score (adverse childhood experiences), and will be asked about basic demographic data. After they complete the initial surveys, the patient will be assigned to either the control group or the experimental group. They will be sent home with the light, along with instructions to use their light every night for 1-2 hours as ambient lighting. The investigators hope to enroll a maximum of 26 patients in this study with 1:1 randomization (13 control, 13 experiment).

At approximately halfway through the intervention, the PI will call the patient and ask how often she has been using the light, how long she uses the light for every night, and whether she has noticed any effects (either positive or negative).

At the prenatal visit around 36 weeks gestation or at time of delivery, whichever is sooner, patients will be asked by the PI to turn in their light and also fill out the STAI once again.

After delivery, the PI will review the medical record and record any change in opioid replacement therapy during pregnancy as well as the total dose of opiate required during the inpatient admission for delivery.

The investigators hope to enroll a maximum of 26 patients in this study with 1:1 randomization (13 control, 13 experiment)

Eligibility criteria: Inclusion Criteria:

Pregnant women between 20 - 32 weeks gestation with a diagnosis of opiate use disorder receiving care through Banner University Medical Center North Mothers Over Medicine (MOMs) Clinic, a high-risk pregnancy clinic for women with substance use disorder complicating pregnancy

Exclusion Criteria:

1. Inability to speak or understand English
2. Incarcerated individuals
3. Age \<18 yo

Primary outcomes:
measure: Change in anxiety over course of intervention, measured by STAI
timeFrame: 4-16 weeks
Secondary outcomes:
measure: Change in Opiate Replacement Therapy
timeFrame: 4-20 weeks
measure: Opiate used during admission for delivery
timeFrame: 1-7 days
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner North Clinic, Obstetrics & Gynecology Clinic
state: Arizona
Study officials:
affiliation: University of Arizona
name: Heather Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Dube SR, Felitti VJ, Dong M, Chapman DP, Giles WH, Anda RF. Childhood abuse, neglect, and household dysfunction and the risk of illicit drug use: the adverse childhood experiences study. Pediatrics. 2003 Mar;111(3):564-72. doi: 10.1542/peds.111.3.564.
citation: Anda RF, Brown DW, Felitti VJ, Dube SR, Giles WH. Adverse childhood experiences and prescription drug use in a cohort study of adult HMO patients. BMC Public Health. 2008 Jun 4;8:198. doi: 10.1186/1471-2458-8-198.
citation: Stein MD, Conti MT, Kenney S, Anderson BJ, Flori JN, Risi MM, Bailey GL. Adverse childhood experience effects on opioid use initiation, injection drug use, and overdose among persons with opioid use disorder. Drug Alcohol Depend. 2017 Oct 1;179:325-329. doi: 10.1016/j.drugalcdep.2017.07.007. Epub 2017 Aug 5.