Trial · NCT04907045
An Initial Study of the Implementation of Digital Therapeutics for Substance Use Disorders in Primary Care
NCT04907045, Not applicable, Completed, Kaiser Permanente; results first posted 2025-08-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Initial Study of the Implementation of Digital Therapeutics for Substance Use Disorders in Primary Care. Trials, record NCT04907045. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04907045
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Initial Study of the Implementation of Digital Therapeutics for Substance Use Disorders in Primary Care
- NCT number
- NCT04907045
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,552 participants, actual
- Lead sponsor
- Kaiser Permanente
- Conditions
- Drug Use Disorders, Illicit Drug Use, Alcohol-Related Disorders
- Interventions
- Health Coaching, Practice Facilitation, Standard Implementation
- First posted
- 2021-05-28
- Last updated
- 2025-08-06
- Results first posted
- 2025-08-06
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reach of the Digital Therapeutic to Patients in the Primary Care Clinic | 6 months | The proportion of patients who initiate the digital therapeutic, defined by instances in which patients open the app, enter the prescription code, and use a treatment module |
| Primary | Fidelity of Patients Use of the Digital Therapeutic to Clinical Recommendations | 9 months | Mean number of weeks in which patients use 4 app modules/week and have visited a clinician in the past month |
| Secondary | Effectiveness | 9 months | Mean number of months in which patients make monthly visits for substance use disorder |
| Other | Reach-3 | 6 months | The proportion of patients who download and unlock reSET or reSET-O |
| Other | Reach-2 | 6 months | The proportion of patients prescribed reSET or reSET-O |
| Other | Fidelity-2 | 9 months | Mean number of weeks in which patients use at least 1 module/week |
| Other | Fidelity-3 | 9 months | Mean number of weeks in which patients use at least 4 modules/week |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Reach of the Digital Therapeutic to Patients in the Primary Care Clinic | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Fidelity of Patients Use of the Digital Therapeutic to Clinical Recommendations | 9 months | Number of weeks | MEAN | |
| SECONDARY | Effectiveness | 9 months | Number of months | MEAN | |
| OTHER_PRE_SPECIFIED | Reach-3 | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Reach-2 | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Fidelity-2 | 9 months | Number of weeks | MEAN | |
| OTHER_PRE_SPECIFIED | Fidelity-3 | 9 months | Number of weeks | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Reach of the Digital Therapeutic to Patients in the Primary Care Clinic | Standard Implementation Plus Health Coaching | 1 | Participants | ||
| Reach of the Digital Therapeutic to Patients in the Primary Care Clinic | Standard Implementation Plus Health Coaching and Practice Facilitation | 4 | Participants | ||
| Fidelity of Patients Use of the Digital Therapeutic to Clinical Recommendations | Standard Implementation Plus Health Coaching | 0 | Standard Deviation 0.06 | Number of weeks | |
| Fidelity of Patients Use of the Digital Therapeutic to Clinical Recommendations | Standard Implementation Plus Health Coaching and Practice Facilitation | 0 | Standard Deviation 0.06 | Number of weeks | |
| Effectiveness | Standard Implementation Plus Health Coaching | 0.01 | Standard Deviation 0.12 | Number of months | |
| Effectiveness | Standard Implementation Plus Health Coaching and Practice Facilitation | 0 | Standard Deviation 0.06 | Number of months | |
| Reach-3 | Standard Implementation Plus Health Coaching | 1 | Participants | ||
| Reach-3 | Standard Implementation Plus Health Coaching and Practice Facilitation | 6 | Participants | ||
| Reach-2 | Standard Implementation Plus Health Coaching | 6 | Participants | ||
| Reach-2 | Standard Implementation Plus Health Coaching and Practice Facilitation | 8 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard Implementation Plus Health Coaching | 296 | |
| Overall Study | STARTED | Standard Implementation Plus Health Coaching and Practice Facilitation | 1,256 | |
| Overall Study | Prescribed | Standard Implementation Plus Health Coaching | 6 | |
| Overall Study | Prescribed | Standard Implementation Plus Health Coaching and Practice Facilitation | 8 | |
| Overall Study | COMPLETED | Standard Implementation Plus Health Coaching | 296 | |
| Overall Study | COMPLETED | Standard Implementation Plus Health Coaching and Practice Facilitation | 1,256 | |
| Overall Study | NOT COMPLETED | Standard Implementation Plus Health Coaching | 0 | |
| Overall Study | NOT COMPLETED | Standard Implementation Plus Health Coaching and Practice Facilitation | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard Implementation Plus Health Coaching | 0 | 6 |
| Total, all-cause mortality | Standard Implementation Plus Health Coaching and Practice Facilitation | 0 | 8 |
| Total, other adverse events | Standard Implementation Plus Health Coaching | 0 | 6 |
| Total, other adverse events | Standard Implementation Plus Health Coaching and Practice Facilitation | 0 | 8 |
| Total, serious adverse events | Standard Implementation Plus Health Coaching | 0 | 6 |
| Total, serious adverse events | Standard Implementation Plus Health Coaching and Practice Facilitation | 0 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39222348 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DA047954 | Digital treatments for opioids and other substance use disorders (DIGITS) in primary care: A hybrid type-III implementation trial | GLASS, JOSEPH EDWIN | KAISER FOUNDATION RESEARCH INSTITUTE | NATIONAL INSTITUTE ON DRUG ABUSE | 2019 to 2023 |
Source NIH RePORTER
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Standard Implementation Plus Health Coaching vs Standard Implementation Plus Health Coaching and Practice Facilitation: Reach-2 | Trial comparisons |
| Standard Implementation Plus Health Coaching vs Standard Implementation Plus Health Coaching and Practice Facilitation: Reach of the Digital Therapeutic to Patients in the Primary Care Clinic | Trial comparisons |
| Standard Implementation Plus Health Coaching vs Standard Implementation Plus Health Coaching and Practice Facilitation: Reach-3 | Trial comparisons |
| Standard Implementation Plus Health Coaching vs Standard Implementation Plus Health Coaching and Practice Facilitation: deaths from any cause | Trial comparisons |
| Standard Implementation Plus Health Coaching vs Standard Implementation Plus Health Coaching and Practice Facilitation: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04907045
GET https://conductscience.org/api/trials/v1/NCT04907045/registered