Substance Use(T-CAP)NCT04911426

Telehealth-Clinical Advocacy Project

A study testing Telehealth in people with Substance Use, run by Texas Christian University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to develop a clinical telehealth intervention and test the feasibility of integrating telehealth within a police opioid county diversion program. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Substance Use
What is being tested?: Telehealth
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 14 Jun 2021to 31 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Individuals interested in joining the study will be
Enrolled in the A Way Out Opioid Diversion Program (ODP),
At least 18 years of age,
Able to speak and understand English,
Have a history of opioid, alcohol, or other substance use within last 12 months,
Be willing to provide the research team with access to treatment records,
Have access to a phone, tablet or computer for the informed consent activity, and
Have a mailing address to receive a study phone issued to consented participants

Who cannot join

Individuals not eligible for the study are
Not currently enrolled in the A Way Out Opioid Diversion Program on the day of consent,
Under the age of 18 on the day of consent,
Unable to speak and understand English,
Have a history of past opioid, alcohol, or other substance use longer than 12 months ago with no use of opioids in the last 12 months,
Unwilling to authorize the research team to access treatment records,
Without access to a phone, tablet or computer to complete the informed consent activity,
Without a mailing address

Trial locations and contacts

1 site in 1 country.

United States1 site

Lake County Public Health Department
Waukegan, Illinois, 60085

Other trials in United States

About this study

The purpose of this study is to develop a clinical telehealth intervention and test the feasibility of integrating telehealth within a police opioid county diversion program.

Read the detailed description

Participants in a police opioid diversion program will receive information about the research opportunity; those interested will be administered informed consent and randomized to either the (1) diversion program treatment as usual condition or (2) the enhanced condition, receiving the telehealth video call intervention with motivational interviewing and substance use treatment appointment reminders during the 12-week intervention. The study design has been modified to provide the enhanced condition with coaching and the T-CAP app to all individuals consented to the study beginning January 1, 2023.

Conditions: Substance Use
Being tested: Telehealth
Keywords: Opioids, Telehealth, Police diversion program
Medical subject headings: Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TelehealthBehavioural
The telehealth intervention is delivered with an app developed for this research. The intervention features live video calling, messaging, appointment reminders; clinical support is provided by licensed clinicians.

Study groups in NCT04911426
Study group	Role	What they receive
Treatment plus telehealth	Experimental	Individuals will receive telehealth support services, including seven brief motivational interviewing sessions, delivered by a licensed substance use counselor via live interactive video calls during the 12-week intervention. Receives: Behavioral: Telehealth

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent of Participants Who Received One or More Referrals During the 12-week Intervention.
The number of participants who received one or more referrals to services made by the intervention coach. This measure is collected as evidence supporting participant utilization of the app and the coaching support model.
Measured: 12-week intervention period
Texas Christian University Drug Screen 5 Severity Score From Baseline to Post Intervention at Week 12
The Texas Christian University Drug Screen 5 is a 19-question survey that captures substance use during the past 12 months. Interpretation of the TCU Drug Screen 5 score for drug use severity corresponds with the Diagnostic and Statistical Manual of Mental Disorders 5 criteria for reporting three possible severity levels (mild, moderate, severe). A single level score is based on participant responses to 11 items (total range: 0 to 11) as such: the presence of 2 to 3 endorsed symptoms is scored as a mild disorder; 4 to 5 endorsed symptoms is scored as moderate disorder; and a severe disorder is scored with the presence of 6 or more symptoms of the 11 items; thus, more endorsed items means a more serious drug use problem.
Measured: Texas Christian University Drug Screen 5 data are reported for baseline and end-of-intervention at 12 weeks after consent.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jun 202131 Jul 2023

First posted3 Jun 2021
Study start14 Jun 2021
Primary completion31 Jul 2023
Study completion31 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Substance UseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Model description: The two-arm randomization has been discontinued with new consented participants joining the study in 2023.
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04911426
Sponsor's protocol ID: 5R21DA048232-02
Other IDs: 5R21DA048232-02
Acronym: (T-CAP)
Status last verified: Apr 2025
First submitted: 5 Apr 2021
Last updated: 18 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Substance Use trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Telehealth-Clinical Advocacy Project
ClinicalTrials.gov ID: NCT04911426
Acronym / sponsor ID: (T-CAP) / 5R21DA048232-02
Conditions: Substance Use
Keywords: Opioids, Telehealth, Police diversion program
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Texas Christian UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 14 Jun 2021 (actual)
Primary completion: 31 Jul 2023 (actual)
Study completion: 31 Jul 2023 (actual)
First posted: 3 Jun 2021 (actual)
Results: Posted 18 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to develop a clinical telehealth intervention and test the feasibility of integrating telehealth within a police opioid county diversion program.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The two-arm randomization has been discontinued with new consented participants joining the study in 2023.

Arm	Type	Receives
Treatment plus telehealth	Experimental	Behavioral: TelehealthIndividuals will receive telehealth support services, including seven brief motivational interviewing sessions, delivered by a licensed substance use counselor via live interactive video calls during the 12-week intervention.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Individuals interested in joining the study will be
Enrolled in the A Way Out Opioid Diversion Program (ODP),
At least 18 years of age,
Able to speak and understand English,
Have a history of opioid, alcohol, or other substance use within last 12 months,

Key exclusion criteria (8 listed)

Individuals not eligible for the study are
Not currently enrolled in the A Way Out Opioid Diversion Program on the day of consent,
Under the age of 18 on the day of consent,
Unable to speak and understand English,
Have a history of past opioid, alcohol, or other substance use longer than 12 months ago with no use of opioids in the last 12 months,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TelehealthThe telehealth intervention is delivered with an app developed for this research. The intervention features live video calling, messaging, appointment reminders; clinical support is provided by licensed clinicians.	Behavioural	Treatment plus telehealth

Primary outcome

Percent of Participants Who Received One or More Referrals During the 12-week Intervention.
Time frame: 12-week intervention period
The number of participants who received one or more referrals to services made by the intervention coach. This measure is collected as evidence supporting participant utilization of the app and the coaching support model.
Texas Christian University Drug Screen 5 Severity Score From Baseline to Post Intervention at Week 12
Time frame: Texas Christian University Drug Screen 5 data are reported for baseline and end-of-intervention at 12 weeks after consent.
The Texas Christian University Drug Screen 5 is a 19-question survey that captures substance use during the past 12 months. Interpretation of the TCU Drug Screen 5 score for drug use severity corresponds with the Diagnostic and Statistical Manual of Mental Disorders 5 criteria for reporting three possible severity levels (mild, moderate, severe). A single level score is based on participant responses to 11 items (total range: 0 to 11) as such: the presence of 2 to 3 endorsed symptoms is scored as a mild disorder; 4 to 5 endorsed symptoms is scored as moderate disorder; and a severe disorder is scored with the presence of 6 or more symptoms of the 11 items; thus, more endorsed items means a more serious drug use problem.

Results and safety

Results posted to the registry on 18 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Plus Telehealth	8	4

Primary outcome: Percent of Participants Who Received One or More Referrals During the 12-week Intervention.

Time frame: 12-week intervention period. Count of participants. Unit: Participants

Measure	Treatment Plus Telehealth n = 6
Value	4

Population analysed: Six of eight consented participants (i.e., the intent-to-treat participants) completed calls with a coach, resulting in four participants (n=66.67%) who received referrals and two participants (n=33.33%) who did not receive a referral. The remaining two participants were not in the intent-to-treat group after randomization was discontinued.

Primary outcome: Texas Christian University Drug Screen 5 Severity Score From Baseline to Post Intervention at Week 12

Time frame: Texas Christian University Drug Screen 5 data are reported for baseline and end-of-intervention at 12 weeks after consent.. Mean (Full Range). Unit: score on a scale

Measure	T-CAP Study Sample n = 4
TCU Drug Screen Baseline scores	9.25 (0 to 11)
Post intervention TCU Drug Screen Scores	9.75 (0 to 11)

Population analysed: Four participants completed the Texas Christian University Drug Screen 5 at baseline and at the end of the intervention (12 weeks after consenting to the study).

Adverse events

Time frame: Adverse event data were collected for a period of 3 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Plus Telehealth	0 of 8 (0%)	2 of 8 (25%)	0 of 8

Limitations and caveats (from the sponsor): The T-CAP project explored the feasibility of implementing a telehealth model in a police diversion program that supports adults in recovery from opioid use disorder with treatment as an alternative to arrest. Inadequate data collection due to enrollment well below the target during the 2019 pandemic limits the ability to draw meaningful conclusions about the impact of the intervention to support people in recovery.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Substance Use

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jennifer Pankow, PhD principal investigator

Texas Christian University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Telehealth in people with Substance Use, run by Texas Christian University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Participants Who Received One or More Referrals During the 12-week Intervention. (time frame: 12-week intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04911426.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.