Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder

Figures & data

Table 1. Participant demographic information.

Variable	TAU (n = 79)^a	TAU + digital therapeutic (n = 91)	Total (n = 170)	p Value
Age (years)
Mean (SD)	33.6 (9.80)	32.2 (9.85)	32.9 (9.82)	.34
Median	31	29	30
Min	19	19	19
Max	63	58	63
Sex
Male	47 (59.5%)	45 (49.5%)	92 (54.1%)	.22
Female	32 (40.5%)	46 (50.5%)	78 (45.9%)
Race
White	75 (94.9%)	87 (95.6%)	162 (95.3%)	.32
Black or African American	4 (5.1%)	2 (2.2%)	6 (3.5%)
Other	0	2 (2.2%)	2 (1.2%)
Other substance dependence
Alcohol	43 (54.4%)	50 (54.9%)	93 (54.7%)	>.99
Cocaine	17 (21.5%)	14 (15.4%)	31 (18.2%)	.33
Benzodiazepines	47 (59.5%)	56 (61.5%)	103 (60.6%)	.88
Methamphetamine	10 (12.7%)	6 (6.6%)	16 (9.4%)	.20
Other drug	57 (72.2%)	67 (73.6%)	124 (72.9%)	.86

Data are mean (SD) or n (%).

^aSeventy-nine participants were found to be randomized to receive TAU and 91 participants to receive TAU + digital therapeutic in the present analysis, whereas 78 participants were reported previously to receive TAU and 92 to receive TAU + digital therapeutic.

Table 2. Abstinence from substance use.

Variable	TAU (n = 79)	TAU + digital therapeutic (n = 91)	Odds ratio (95% CI)	p Value
Primary endpoint (weeks 9–12)
Total abstinence from opioids and cocaine	60.6%	75.9%	2.05 (1.07, 3.90)	.03
Abstinence from opioids only	62.1%	77.3%	2.08 (1.10, 3.95)	.02
Abstinence from cocaine only	64.5%	82.4%	2.58 (1.37, 4.86)	.003
Secondary endpoint (weeks 0–12)
Total one-third weeks abstinent	24.06 (11.89)	27.97 (8.17)		.02
Exploratory endpoint (weeks 5–12)
Abstinence from opioids (weeks 7–12)	63.9%	78.2%	2.03 (1.09, 3.80)	.03
Abstinence from opioids (weeks 5–12)	68.5%	82.4%	2.16 (1.16, 4.01)	.01

Data are proportion of participants (%) or mean (SD).

Figure 1. Kaplan-Meier estimates of time to withdrawal from treatment.

Table 3. Summary of adverse events.

Variable	TAU (n = 79)	TAU + digital therapeutic (n = 91)	Total (n = 170)	p Value
Participants reporting at least one adverse event	55 (69.6%)	57 (62.6%)	112 (65.9%)	.42
Adverse events^a
Gastrointestinal disorders	23 (29.1%)	23 (25.3%)	46 (27.1%)
Musculoskeletal and connective tissue disorders	18 (22.8%)	18 (19.8%)	36 (21.2%)
Psychiatric disorders	19 (24.1%)	17 (18.7%)	36 (21.2%)
Nervous system disorders	13 (16.5%)	21 (23.1%)	34 (20.0%)
General disorders and administration site conditions	11 (13.9%)	17 (18.7%)	28 (16.5%)
Skin and subcutaneous tissue disorders	9 (11.4%)	8 (8.8%)	17 (10.0%)
Infections and infestations	5 (6.3%)	8 (8.8%)	13 (7.6%)
Investigations	3 (3.8%)	10 (11.0%)	13 (7.6%)
Respiratory, thoracic and mediastinal disorders	5 (6.3%)	7 (7.7%)	12 (7.1%)
Injury, poisoning and procedural complications	3 (3.8%)	4 (4.4%)	7 (4.1%)
Eye disorders	1 (1.3%)	5 (5.5%)	6 (3.5%)
Metabolism and nutrition disorders	1 (1.3%)	2 (2.2%)	3 (1.8%)
Reproductive system and breast disorders	0	3 (3.3%)	3 (1.8%)
Renal and urinary disorders	0	2 (2.2%)	2 (1.2%)
Hepatobiliary disorders	0	1 (1.1%)	1 (0.6%)
Pregnancy, puerperium and perinatal conditions	1 (1.3%)	0	1 (0.6%)
Surgical and medical procedures	1 (1.3%)	0	1 (0.6%)
Vascular disorders	0	1 (1.1%)	1 (0.6%)

Data are n (%).

^aAdverse events coded using preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA) system organ classifications.