Trial Outcomes & Findings for Stress, Distress Intolerance, and Drug Dependence (NCT NCT00430482)

Last Updated: 2019-07-10

Results Overview

The primary outcome assessment for this study was the percentage of oral toxicology swabs that were positive of illicit substances. Participants completed these swabs at each assessment point, as well as at each study therapy session. Toxicology swabs were supervised by study staff and used oral specimen collection to screen for opiates, methadone, cocaine, benzodiazepines, amphetamines, THC, and barbiturates.

Recruitment status

COMPLETED

Study phase

Target enrollment

133 participants

Primary outcome timeframe

Weekly assessments with summation over three time periods: baseline, treatment, and eight weeks of follow-up.

Results posted on

2019-07-10

Participant Flow

Participants were recruited via study flyers and postings or were referred to study staff by their substance abuse counselor.

133 individuals were consented. Eleven dropped out prior to SCID administration. At the intake visit, 27 individuals were deemed ineligible. Of the 95 individuals who were eligible, 17 dropped out prior to randomization (7 were discharged, 2 declined treatment, and 8 were lost to contact). A total of 78 individuals were randomized to treatment.

Participant milestones

Participant milestones
Measure	Cognitive Behavioral Therapy Cognitive Behavioral Therapy Cognitive Behavioral Therapy: 12 weekly sessions and 3 booster sessions of cognitive behavioral therapy	Individual Drug Counseling Individual Drug Counseling Individual Counseling: 12 weekly sessions and 3 booster sessions of individual counseling
Completed Treatment STARTED	41	37
Completed Treatment Completed ASI at Midpoint	35	29
Completed Treatment COMPLETED	34	26
Completed Treatment NOT COMPLETED	7	11
Completed 2 Follow-Up Visits STARTED	34	26
Completed 2 Follow-Up Visits Completed ASI at Follow-Up #1	27	20
Completed 2 Follow-Up Visits Completed ASI at Follow-Up #2	29	20
Completed 2 Follow-Up Visits COMPLETED	29	20
Completed 2 Follow-Up Visits NOT COMPLETED	5	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Cognitive Behavioral Therapy Cognitive Behavioral Therapy Cognitive Behavioral Therapy: 12 weekly sessions and 3 booster sessions of cognitive behavioral therapy	Individual Drug Counseling Individual Drug Counseling Individual Counseling: 12 weekly sessions and 3 booster sessions of individual counseling
Completed Treatment Insufficient Treatment	7	11

Baseline Characteristics

Stress, Distress Intolerance, and Drug Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive Behavior Therapy n=41 Participants Psychosocial treatment with an individualized therapy emphasizing interoceptive exposure and training alternative responses to cues for drug use	Individual Drug Counseling n=37 Participants Psychosocial treatment with individual drug counseling	Total n=78 Participants Total of all reporting groups
Age, Continuous	42.2 years STANDARD_DEVIATION 9.8 • n=99 Participants	42.4 years STANDARD_DEVIATION 10.0 • n=107 Participants	42.3 years STANDARD_DEVIATION 9.9 • n=206 Participants
Sex: Female, Male Female	18 Participants n=99 Participants	17 Participants n=107 Participants	35 Participants n=206 Participants
Sex: Female, Male Male	23 Participants n=99 Participants	20 Participants n=107 Participants	43 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=99 Participants	3 Participants n=107 Participants	8 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=99 Participants	34 Participants n=107 Participants	70 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	14 Participants n=99 Participants	11 Participants n=107 Participants	25 Participants n=206 Participants
Race (NIH/OMB) White	27 Participants n=99 Participants	26 Participants n=107 Participants	53 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	41 Participants n=99 Participants	37 Participants n=107 Participants	78 Participants n=206 Participants

PRIMARY outcome

Timeframe: Weekly assessments with summation over three time periods: baseline, treatment, and eight weeks of follow-up.

Population: Randomized participants

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy n=41 Participants Cognitive Behavioral Therapy Cognitive Behavioral Therapy: 12 weekly sessions and 3 booster sessions of cognitive behavioral therapy	Individual Drug Counseling n=37 Participants Individual Drug Counseling Individual Counseling: 12 weekly sessions and 3 booster sessions of individual counseling
Percentage of Positive Toxicology Swabs for Illicit Substances Baseline Period	81.3 percentage of positive toxicology screen Standard Deviation 24.3	79.1 percentage of positive toxicology screen Standard Deviation 33.8
Percentage of Positive Toxicology Swabs for Illicit Substances Treatment Period	86.2 percentage of positive toxicology screen Standard Deviation 18.7	82.3 percentage of positive toxicology screen Standard Deviation 24.3
Percentage of Positive Toxicology Swabs for Illicit Substances Follow-Up Period	77.6 percentage of positive toxicology screen Standard Deviation 27.4	74.8 percentage of positive toxicology screen Standard Deviation 30.7

SECONDARY outcome

Timeframe: Baseline, Mid Treatment, Treatment Endpoint, Follow-up Evaluation 1, Follow-up Evaluation 2

Population: Randomized participants

The composite score for drug use is determined by answers to 13 questions on the ASI: A/390 + B/390 + C/390 + D/390 + E/390 + F/390 + G/390 +H/390 + I/390 + J/390 + K/390 + L/52 + M/52. A single score is provided, with possible scores ranging from 0 to 1, with higher scores indicate greater drug use.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy n=41 Participants Cognitive Behavioral Therapy Cognitive Behavioral Therapy: 12 weekly sessions and 3 booster sessions of cognitive behavioral therapy	Individual Drug Counseling n=37 Participants Individual Drug Counseling Individual Counseling: 12 weekly sessions and 3 booster sessions of individual counseling
Addiction Severity Index (ASI) Drug Composite Index Baseline	.23 units on a scale Standard Deviation .09	.21 units on a scale Standard Deviation .12
Addiction Severity Index (ASI) Drug Composite Index Mid Treatment	.20 units on a scale Standard Deviation .07	.16 units on a scale Standard Deviation .10
Addiction Severity Index (ASI) Drug Composite Index Treatment Endpoint	.17 units on a scale Standard Deviation .09	.18 units on a scale Standard Deviation .13
Addiction Severity Index (ASI) Drug Composite Index Follow Up 1	.16 units on a scale Standard Deviation .09	.18 units on a scale Standard Deviation .11
Addiction Severity Index (ASI) Drug Composite Index Follow-Up 2	.16 units on a scale Standard Deviation .12	.16 units on a scale Standard Deviation .12

Adverse Events

Cognitive Behavioral Therapy

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

Individual Drug Counseling

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Michael W. Otto, Ph.D.

Boston University Charles River Campus

Phone: (617)353-9610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Cognitive Behavioral Therapy n=41 participants at risk Cognitive Behavioral Therapy Cognitive Behavioral Therapy: 12 weekly sessions and 3 booster sessions of cognitive behavioral therapy	Individual Drug Counseling n=37 participants at risk Individual Drug Counseling Individual Counseling: 12 weekly sessions and 3 booster sessions of individual counseling
General disorders Foot Ulcer	2.4% 1/41 • Number of events 1 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.	0.00% 0/37 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.
Injury, poisoning and procedural complications Ankle Sprain	2.4% 1/41 • Number of events 1 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.	0.00% 0/37 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.
Renal and urinary disorders Kidney infection	2.4% 1/41 • Number of events 1 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.	0.00% 0/37 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.
Injury, poisoning and procedural complications Hairline fracture	0.00% 0/41 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.	2.7% 1/37 • Number of events 1 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.
Psychiatric disorders Oversedation	0.00% 0/41 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.	2.7% 1/37 • Number of events 1 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.
Renal and urinary disorders Groin Injury	2.4% 1/41 • Number of events 1 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.	0.00% 0/37 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/41 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.	2.7% 1/37 • Number of events 1 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.
Endocrine disorders High Glucose Levels	0.00% 0/41 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.	2.7% 1/37 • Number of events 1 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.
Respiratory, thoracic and mediastinal disorders Respiratory Problems	2.4% 1/41 • Number of events 1 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.	0.00% 0/37 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.
Psychiatric disorders Detoxification	0.00% 0/41 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.	2.7% 1/37 • Number of events 1 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.
Psychiatric disorders Depression	2.4% 1/41 • Number of events 1 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.	0.00% 0/37 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.
Blood and lymphatic system disorders Blood Clot	0.00% 0/41 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.	2.7% 1/37 • Number of events 1 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.
General disorders Hospitalization for Chronic Health Concerns	0.00% 0/41 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.	2.7% 1/37 • Number of events 1 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.
General disorders Infection	0.00% 0/41 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.	2.7% 1/37 • Number of events 1 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.
Psychiatric disorders Suicidal Ideation	0.00% 0/41 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.	2.7% 1/37 • Number of events 1 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.
Injury, poisoning and procedural complications Stab Wound	0.00% 0/41 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.	2.7% 1/37 • Number of events 1 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.
Renal and urinary disorders Kidney Stone	2.4% 1/41 • Number of events 1 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.	0.00% 0/37 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.
Metabolism and nutrition disorders Dehydration	0.00% 0/41 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.	2.7% 1/37 • Number of events 1 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.
Injury, poisoning and procedural complications Wound Treatment	0.00% 0/41 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.	2.7% 1/37 • Number of events 1 • Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed. Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures. Adverse events (AEs) were not assessed in this study.