Alcohol WithdrawalNCT03737864
NCARE, Transition to Recovery
A study testing Patient navigation and Motivational interviewing (MI) in people with Alcohol Withdrawal and Substance Use Disorders, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study tests the effectiveness of patient navigation for increasing enrollment in substance abuse treatment programs and preventing readmission to detoxification. Participants will be randomized to receive motivational interviewing or motivation interviewing plus patient navigation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Withdrawal, Substance Use Disorders
- What is being tested?
- Patient navigation and Motivational interviewing (MI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2019to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 18 years or older.
- successful completion of the detoxification process (completion of the detoxification process is a necessary step in order to transitions to substance abuse treatment) from our partnering detoxification facility.
- no comorbid physical or mental health condition (e.g., cancer, severe suicidality) that would delay transition to alcohol treatment.
- willing and cognitively able to provide informed consent and complete all study procedures assessed by detoxification discharge nurses.
- not currently admitted to a substance abuse treatment program
Who cannot join
- discharge destination prison or jail
- already enrolled in substance abuse treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Native Center for Alcohol Research and Education (NCARE), Transition to Recovery
This study tests the effectiveness of patient navigation for increasing enrollment in substance abuse treatment programs and preventing readmission to detoxification. Participants will be randomized to receive motivational interviewing or motivation interviewing plus patient navigation.
Read the detailed description
The primary goal of alcohol detoxification is to medically manage acute intoxication and withdrawal. Its secondary goal of fostering entry into longer-term alcohol treatment post-detoxification is often overlooked. This leads to a revolving door characterized by a cyclical pattern of discharges and re-admissions to detoxification. This pattern is observed across the US among alcohol detoxification patients and is even more prevalent among Alaska Native people; few transition to alcohol treatment following detoxification and approximately 40% are readmitted within 1 year. The revolving door is costly to patients and providers. Current estimates associated with the cost of detoxification are not available. A study over 25 years ago indicated the average inpatient detoxification stay was over $3,300. Although the Substance Abuse and Mental Health Administration recognizes that better linkages are needed to transition people to treatment following detoxification, few interventions have tested ways to improve this transition; none of these prior studies included either Alaska Natives or American Indians.
This study proposes to use patient navigators to guide and assist patients in their transition to the appropriate levels of treatment, and to help eliminate barriers that obstruct treatment entry. This is a randomized controlled trial of the patient navigation intervention with 612 patients. We will estimate the costs of implementing and sustaining this intervention as well as its economic value. The control condition will include 1 session of motivational interviewing lasting approximately 45 minutes to 1 hour. The intervention group will also receive motivational interviewing and in addition will work with a patient navigator to facilitate entry into the appropriate level of care and provide ongoing support until the patient is admitted to treatment or the intervention period ends.
Specific Aims:
- Adapt patient navigation (Transitions to Recovery) to fit the patient population and test its effectiveness in increasing successful transition to post-detoxification substance abuse treatment.
- Test patient navigation's effectiveness in preventing readmission to detoxification.
- Perform a comprehensive economic evaluation of patient navigation (Transition to Recovery) by using cost-benefit analyses.
If effective, this intervention may be a cost-effective means of transitioning detoxification patients to treatment across health care systems nationally.
- Conditions
- Alcohol Withdrawal, Substance Use Disorders
- Being tested
- Patient navigation, Motivational interviewing (MI)
- Keywords
- transition to substance abuse treatment, readmission, recidivism, patient navigation
- Medical subject headings
- Substance-Related Disorders, Recidivism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient navigationBehavioural
The patient navigator will provide support to patients upon discharge and will maintain regular contact either in person or by phone at a minimum of once per week for 30 days, or until the patient successfully enrolled in substance abuse treatment, or readmission to detoxification occurs, whichever occurs first.
Motivational interviewing (MI)Behavioural
A single 45-60 minute 1:1 session of MI provided by patient navigators at discharged focused on transitioning patients to treatment after detoxification.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interview | Active comparator | A single 45-60 minute 1:1 session of MI provided by patient navigators at discharged focused on transitioning patients to treatment after detoxification. Receives: Behavioral: Motivational interviewing (MI) |
| Patient navigation and MI | Experimental | A single 45-60 minute 1:1 session of MI provided by patient navigators at discharged focused on transitioning patients to treatment after detoxification plus patient navigation for 30 days, or until the patient is successfully enrolled in substance abuse treatment, or readmission to detoxification occurs, whichever occurs first. Receives: Behavioral: Patient navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transition to substance abuse treatment
The date of entry into a substance abuse treatment program will be collected. A calculated a variable that reflects the number of days between detoxification discharge and transition to substance abuse treatment, and a binary indicator of successful transition to treatment within 0 to 30 days.
Measured: 30 days
Secondary outcomes (1)
Readmission to detoxification
Extract the date of the first readmission (if one occurs) or collect at 6 and 12 month follow-up following discharge from detoxification and calculate a variable indicating total days to readmission within one year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start17 Jun 2019
- Primary completion15 May 2023
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol WithdrawalStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Spero M Manson, PhD, Principal investigator, University of Colorado, DenverMichael McDonell, PhD, Study director, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737864
- Sponsor's protocol ID
- 18-2421
- Status last verified
- Mar 2025
- First submitted
- 7 Nov 2018
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Running Bear U, Poole EM, Muller C, Hanson JD, Noonan C, Trojan J, Rosenman R, Manson SM. The use of patient navigation to transition detoxification patients to substance use treatment in the Alaska Interior. Public Health Pract (Oxf). 2023 Aug 6;6:100418. doi: 10.1016/j.puhip.2023.100418. eCollection 2023 Dec.
PubMed 37635913
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Native Center for Alcohol Research and Education (NCARE), Transition to Recovery
- ClinicalTrials.gov ID
- NCT03737864
- Acronym / sponsor ID
- 18-2421
- Conditions
- Alcohol Withdrawal, Substance Use Disorders
- Keywords
- transition to substance abuse treatment, readmission, recidivism, patient navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests the effectiveness of patient navigation for increasing enrollment in substance abuse treatment programs and preventing readmission to detoxification. Participants will be randomized to receive motivational interviewing or motivation interviewing plus patient navigation.
Detailed description
The primary goal of alcohol detoxification is to medically manage acute intoxication and withdrawal. Its secondary goal of fostering entry into longer-term alcohol treatment post-detoxification is often overlooked. This leads to a revolving door characterized by a cyclical pattern of discharges and re-admissions to detoxification. This pattern is observed across the US among alcohol detoxification patients and is even more prevalent among Alaska Native people; few transition to alcohol treatment following detoxification and approximately 40% are readmitted within 1 year. The revolving door is costly to patients and providers. Current estimates associated with the cost of detoxification are not available. A study over 25 years ago indicated the average inpatient detoxification stay was over $3,300. Although the Substance Abuse and Mental Health Administration recognizes that better linkages are needed to transition people to treatment following detoxification, few interventions have tested ways to improve this transition; none of these prior studies included either Alaska Natives or American Indians.
This study proposes to use patient navigators to guide and assist patients in their transition to the appropriate levels of treatment, and to help eliminate barriers that obstruct treatment entry. This is a randomized controlled trial of the patient navigation intervention with 612 patients. We will estimate the costs of implementing and sustaining this intervention as well as its economic value. The control condition will include 1 session of motivational interviewing lasting approximately 45 minutes to 1 hour. The intervention group will also receive motivational interviewing and in addition will work with a patient navigator to facilitate entry into the appropriate level of care and provide ongoing support until the patient is admitted to treatment or the intervention period ends.
Specific Aims:
- Adapt patient navigation (Transitions to Recovery) to fit the patient population and test its effectiveness in increasing successful transition to post-detoxification substance abuse treatment.
- Test patient navigation's effectiveness in preventing readmission to detoxification.
- Perform a comprehensive economic evaluation of patient navigation (Transition to Recovery) by using cost-benefit analyses.
If effective, this intervention may be a cost-effective means of transitioning detoxification patients to treatment across health care systems nationally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interview | Active comparator | Behavioral: Motivational interviewing (MI)A single 45-60 minute 1:1 session of MI provided by patient navigators at discharged focused on transitioning patients to treatment after detoxification. |
| Patient navigation and MI | Experimental | Behavioral: Patient navigationA single 45-60 minute 1:1 session of MI provided by patient navigators at discharged focused on transitioning patients to treatment after detoxification plus patient navigation for 30 days, or until the patient is successfully enrolled in substance abuse treatment, or readmission to detoxification occurs, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older.
- successful completion of the detoxification process (completion of the detoxification process is a necessary step in order to transitions to substance abuse treatment) from our partnering detoxification facility.
- no comorbid physical or mental health condition (e.g., cancer, severe suicidality) that would delay transition to alcohol treatment.
- willing and cognitively able to provide informed consent and complete all study procedures assessed by detoxification discharge nurses.
- not currently admitted to a substance abuse treatment program
Key exclusion criteria (2 listed)
- discharge destination prison or jail
- already enrolled in substance abuse treatment
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 |
|---|---|---|
| Patient navigationThe patient navigator will provide support to patients upon discharge and will maintain regular contact either in person or by phone at a minimum of once per week for 30 days, or until the patient successfully enrolled in substance abuse treatment, or readmission to detoxification occurs, whichever occurs first. | Behavioural | Patient navigation and MI |
| Motivational interviewing (MI)A single 45-60 minute 1:1 session of MI provided by patient navigators at discharged focused on transitioning patients to treatment after detoxification. | Behavioural | Motivational Interview |
Primary outcome
Transition to substance abuse treatment
Time frame: 30 days
The date of entry into a substance abuse treatment program will be collected. A calculated a variable that reflects the number of days between detoxification discharge and transition to substance abuse treatment, and a binary indicator of successful transition to treatment within 0 to 30 days.
1 secondary outcome
Readmission to detoxification
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Derived from this study: PubMed 37635913Running Bear U, Poole EM, Muller C, Hanson JD, Noonan C, Trojan J, Rosenman R, Manson SM. The use of patient navigation to transition detoxification patients to substance use treatment in the Alaska Interior. Public Health Pract (Oxf). 2023 Aug 6;6:100418. doi: 10.1016/j.puhip.2023.100418. eCollection 2023 Dec.
- Individual participant dataSharing planned: No
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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.
Spero M Manson, PhD principal investigator
University of Colorado, Denver
Michael McDonell, PhD study director
Washington State 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 Patient navigation and Motivational interviewing (MI) in people with Alcohol Withdrawal and Substance Use Disorders, run by University of Colorado, Denver 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 5 inclusion and 2 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 25 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Transition to substance abuse treatment (time frame: 30 days). 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 NCT03737864, which also lists 1 linked publication.
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 25 Mar 2025.