Safety and efficacy of a digital therapeutic for substance use disorder: Secondary analysis of data from a NIDA clinical trials network study

Figures & data

Table 1. Demographics and Baseline Characteristics.*

Outcome	rTAU + reSET (n = 206)	TAU (n = 193)
Mean age at screening (± standard deviation)	37.1 (10.87)	35.4 (10.97)
Female sex – no. (%)	73 (35.4%)	85 (44.0%)
Race
White	98 (47.6%)	94 (48.7%)
Black or African American	65 (31.6%)	45 (23.3%)
Asian	5 (2.4%)	7 (3.6%)
Native Hawaiian or Pacific Islander	7 (3.4%)	5 (2.6%)
Multiracial	20 (9.7%)	29 (15.0%)
American Indian or Alaska native	2 (1.0%)	1 (0.5%)
Other	9 (4.4%)	12 (6.2%)
Education
Less than high school diploma	43 (20.9%)	45 (23.3%)
High school diploma or equivalent	134 (65.0%)	117 (60.6%)
More than high school diploma	29 (14.1%)	31 (16.1%)
Primary substance used
Alcohol	58 (28.2%)	46 (23.8%)
Cocaine	53 (25.7%)	49 (25.4%)
Stimulants	33 (16.0%)	36 (18.7%)
Cannabis	54 (26.2%)	60 (31.1%)
Other	8 (3.9%)	2 (1.0%)

*There were no significant differences in any of these characteristics (p > 0.05).

Table 2. Model-Based Abstinence Rates.

Abstinence outcome	rTAU + reSET (n = 206)	TAU (n = 193)	Odds ratio (95% confidence interval)	p-Value
Primary outcome of percentage of study participants abstinent at weeks 9–12	40.3%	17.6%	3.17 (1.68, 5.99)	<0.001
Number of participants abstinent at baseline	n = 105	n = 102
Percentage of study participants abstinent at baseline and abstinent at weeks 9–12	65.1%	45.7%	2.22 (1.15, 4.27)	0.02
Number of participants not abstinent at baseline	n = 101	n = 91
Percentage of study participants not abstinent at baseline and abstinent at weeks 9–12	16.1%	3.2%	5.74 (1.99, 16.60)	0.001

Table 3. Frequency of Reported Adverse Events.

Adverse events	rTAU + reSET (n = 206)	TAU (n = 193)	p-Value
Number of study participants with adverse events	32 (15.5%)*	27 (14.0%)	0.68
Number of study participants with suicide-related events	7 (3.4%)	4 (2.1%)	0.55

*One event of stress of moderate severity following a positive urine drug test in a patient in the rTAU + reSET was considered related to the study procedure and was not considered related to the study intervention (reSET). This event was resolved by allowing the participant to continue in the study without providing urine samples.