Reliability, Validity, and Acceptability of a Novel Visual Scale for Estimating Daily Methamphetamine Use Among People Who Use Methamphetamine

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-40
SponsorPhillip Coffin, MD, MIA

About this trial

PROJECT RESIN: This study is examining the reliability, validity, and acceptability of a novel visual scale for estimating daily methamphetamine use among people who use methamphetamine.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 20-40 inclusive

English speaking

Self-reports using methamphetamine at least once in the past 7 days (attempts will be made to enroll participants with varied frequencies of methamphetamine use)

At least 1cm of untreated occipital scalp hair

Disqualifiers

Participant, in the opinion of the investigators, would be unable to complete study procedures

Trial population

Adults 20-40 years old who use methamphetamine and have scalp hair.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: Resin Cohort

Trial outcomes

Primary outcomes

1

Reliability - Timeline Follow-back

The methamphetamine analog visual scale (MAVS) will be administered with the timeline follow-back (TLFB) at V0 and V1, which are 7-14 days apart. Each TLFB will assess 30 days prior to the date of assessment. The reliability outcome will compare within-subject reliability of meth use on overlapping days of TLFB using MAVS.

Time frame
Conducted at enrollment (V0) and follow-up (V1) to record meth use 30 days from those dates. The data will be collected as amount per day for 30 days.
2

Validity - Hair Sample

To assess validity, we will compare the hair sampling analysis and self-reported meth use via the MAVS/TLFB. Methamphetamine levels are determined by liquid chromatography tandem mass spectrometry (LC/MS/MS) using a Micromass Quattro Ultima and Shimadzu HPLC system equipped with a Phenomenex Synergi Polar-RP column (4.6 x 150 mm, 4 μm particle size), a mobile phase system consisting of acetonitrile:water:trifluoro acetic acid (20:80:0.05), and mass spectrometric detection with positive ionization by electrospray ionization and mass scanning by multiple reaction monitoring (\[M+H\]+ transitions of 150/119 (Q1/Q3) m/z for methamphetamine and 159/125 m/z for deuterated methamphetamine). The standard curve range of methamphetamine by LC/MS/MS analysis is 0.00800 nanograms (ng)/mg (lower limit) to 3.20 ng/mg of hair.

Time frame
Hair sample will be collected at the enrollment visit
3

Validity - Weighted Surrogate Assessment

Participants will work with the researchers to measure out a quantity of a non-psychoactive drug surrogate onto a physical milligram scale until the participant reports that the quantity matches their daily use. The min value of this scale is 0 and there is no max value. The actual score does not represent a better or worse outcome, rather we are comparing it to the reported value. To avoid potential use triggers associated with this procedure, it will be performed in a professional and clinical fashion, with the phenethylamine kept in laboratory glassware and handled with gloves and tweezers. This will be compared to the reported value to assess validity. This will be conducted at V0 and V1.

Time frame
At enrollment visit (V0) and at follow-up visit (V1). The data will be collected as amount per day for the most recent day of use.
4

Acceptability Questionnaire

A questionnaire will be administered to assess the acceptability of the MAVS among people who use methamphetamine. This will be performed V1 and will consist of several 5-point Likert scale questions on the MAVS' ease of use, relevance to use patterns, and whether seeing the drug surrogate triggers a desire to use. A higher value on the scale measures higher acceptability.

Time frame
Follow-up visit (V1). The questionnaire will cover the time frame of the study, which will be 7-14 days.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Phillip Coffin, MD, MIA

Lead sponsor

San Francisco Department of Public Health

Sponsor institution

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