Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04893044 |
| Other study ID # |
190366 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 16, 2019 |
| Est. completion date |
October 10, 2019 |
Study information
| Verified date |
May 2021 |
| Source |
University of New Mexico |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
A pilot trial among ship-board US Navy personnel surrounding a holiday weekend tested an
evidence-based video on responsible drinking.
Service members >18 years were eligible to volunteer if they were aboard during data
collection. Participants were randomized to intervention or control arms, with all given a
brief survey before (T1) and after (T2) the weekend. The intervention arm viewed a 3-minute
video at T1. A urine specimen collected at T1 and T2 for ethyl glucuronide (EtG) measurement
used >100ng/ml for significant alcohol use. Multivariable regression measured odds of
detecting EtG at T2, controlling for T1 EtG detectability, age, and alcohol misuse at
baseline per AUDIT-C.
86 subjects participated at T1, and 100 at T2, with complete data for 72 (control, n=34;
intervention, n=38) who participated in both T1 and T2 were analyzed. Average age was 28
years with 25% and 32% reporting white or black/African-American, 54% married and 84% <E6. At
T1, 22% (n=16) and T2, 32% (n=23) had EtG>100ng/ml. At T1, 50% and 55% in control and
intervention arms respectively, screened positive for alcohol misuse by AUDIT-C; T1 AUDIT-C
screen positivity was significantly associated with detecting EtG>100ng/ml at T1 (p=0.04).
Control arm EtG>100ng/ml participants increased 1.7-fold over the weekend, from n=7 at T1 to
n=12 at T2; the intervention arm had no increase in EtG>100ng/ml participants, with n=11 at
T1 and n=11 at T2.
Description:
U.S. Navy active duty personnel were recruited to participate in a randomized pilot trial
evaluating the efficacy of a 3 minute video intervention designed to promote safer drinking
and reduce adverse consequences of alcohol use. All subjects were provided informed consent
prior to participation. An incentive of a $5 gift card was provided upon completion of T1,
and a $10 gift card provided after completion of T2. Subject participation and data were
anonymous; personal identifiers were collected in order to link samples and surveys between
timepoint 1 (T1) and timepoint 2 (T2), but after the linking, all identifier data were
destroyed. To minimize risk associated with collecting personal identifiers, we did not
retain any personal identifiers, to include sex categorization of participants. Subjects
completed the T1 survey with only study ID on the form and were then asked to provide a urine
sample.
Urine samples were collected in toilet facilities onboard the ship. The collections were not
monitored. Urine samples were labelled with the subject ID number and stored at 4 degrees C
until they could be shipped. For T1, samples remained refrigerated over the weekend as
receiving personnel would not be available during the weekend; at T2, the samples were
shipped the following day.
At T1, after providing the urine sample, the intervention subjects watched a 3 minute video,
while the control subjects left the area without watching the video.
After the long weekend, subjects were asked to return to the study area, complete a brief
survey, and provide a second urine specimen.
The 3 minute video was created for this pilot study. One of the authors with experience in
inoculation theory (RJD) guided the content of the video, which was produced, directed and
filmed at the New York University Film School.
The T1 surveys collected data on year of birth (as a verification in linking T1 and T2 data
in event of linking error), demographic information to include race, relationship status, and
pay grade. Additional questions included "have you ever had a drinking problem?", the AUDIT-C
questions , and questions regarding if conflicts, accidents or other issues had occurred as a
result of alcohol use.
The T2 survey collected year of birth (see above), AUDIT-C questions (modified to reflect
data only from the preceding weekend), and the same questions regarding conflicts, accidents
or other issues as a result of alcohol use.
Procedure for EtG testing Chemicals and materials Standards of ethyl glucuronide (EtG) and
ethyl glucuronide-d5 (EtG-d5) were purchased at concentrations of 1 mg/mL in 1 mL methanol
from Cerilliant Corp (Round Rock, TX, US). Liquid chromatography-mass spectrometry (LC-MS)
grade methanol, acetonitrile and formic acid, and Sarstedt Inc 10 mL sc tubes 16x100 mm were
purchased from Thermo Fisher Scientific (Waltham, MA, US). Nano-Filter vials ® 0.2 µm PES
with pre-slit gray cap were from Thomson Instrument Company (Oceanside, CA, US).
Sample preparation: dilution and filtration One hundred µL of urine sample, 300 µL of water
and 100 µL of the internal standard EtG-d5 at 0.5 µg/mL were vortex-mixed in a clean
Starstedt tube. Two hundred µL of the sample were transferred into the shell vial of the
Filter Vial. The plunger with filter was inserted all the way into the shell vial. Twenty µL
of the filtered sample were directly injected into the LC-MS/MS.
Calibrators were prepared at concentrations 0.05, 0.1, 0.25, 0.5, 1, 5 and 10 µg/mL, and
quality controls at 0.15 and 7.5 µg/mL, using 100 µL of blank urine, 200 µL of water, 100 µL
of the corresponding working solution and 100 µL of the internal standard solution.
Instrumental analysis The chromatographic separation was carried out on a Nexera UHPLC system
(Shimadzu, Columbia, MD, US). The Nexera UHPLC system consisted of two binary LC-20AD XR
high-performance liquid chromatography pumps, online degassing unit (DGU-20A 3R), cooled
autosampler (SIL-20A XR) and an oven (CTO-20AC). The column was a Hypercarb column (2.1x 100
mm, 3 µm) from Thermo Fisher Scientific. The mobile phase, 0.1 % formic acid in water (A) and
acetonitrile (B), was delivered at a flow rate of 0.3 mL/min. Column temperature was 30C. The
gradient began with B at 5% then increasing to 95% in 6 min. B at 95% was held for 0.5 min
after which it decreased to 5%, and it was held for 1 min. Total run time was 7.5 min.
The mass spectrometer was a triple quadrupole LCMS-8050 from Shimadzu equipped with
electrospray ionization source (ESI). The heating gas and drying gas flows were 15 and 10
L/min, respectively, with a nebulizing gas flow at 2 L/min. The interface temperature was
300°C and the heat block temperature was 400°C. All compounds were analyzed using ESI in
negative ionization mode, and two transitions in multiple reaction monitoring (MRM) mode were
acquired for each analyte.
Statistical analysis Statistical analyses were performed using Stata version 15.1 (StataCorp,
College Station, TX). Descriptive statistics were calculated to characterize participant
demographics and by alcohol use at T1 and T2. Fisher's exact tests were used for categorical
variables with n<15 in any category and Wilcoxon rank-sum tests for non-normally distributed
continuous variables to examine bivariate associations between the groups. All tests were
two-sided with significance level of 0.05.
