Drug DependenceNCT02124980
Automated Recovery Line for Medication Assisted Treatment
A study testing Recovery Line in people with Drug Dependence and Substance Use Disorders, run by Yale University at 1 site in United States.
Trial summary
If shown to be effective, the Recovery Line would provide an inexpensive, transportable, and easy to use treatment to improve substance abuse outcomes for medication assisted treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Dependence, Substance Use Disorders
- What is being tested?
- Recovery Line
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Apr 2017
- 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
- are at least 18 years old
- currently receiving methadone maintenance treatment
- illicit drug use in the past 14 days or a positive urine screen for any tested illicit drug.
Who cannot join
- Current suicide or homicide risk
- meet criteria for Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV current psychotic disorder, or bipolar disorder
- Unable to read or understand English
- Unable to complete the study because of anticipated incarceration or move
- Life-threatening or unstable medical problems.
Trial locations and contacts
1 site in 1 country.
United States1 site
MRU, APT Foundation, Inc
New Haven, Connecticut, 06519
About this study
If shown to be effective, the Recovery Line would provide an inexpensive, transportable, and easy to use treatment to improve substance abuse outcomes for medication assisted treatment. Given the high costs of relapse and continued drug use, improvement of treatment outcomes would provide substantial health, economic, and societal benefits.
Read the detailed description
Dependence on heroin and prescription pain relievers has almost tripled since 2000, resulting in dramatic increases in opioid dependence treatment admissions. However, among agonist-maintained patients continued drug use is common and associated with high rates of relapse and treatment drop-out. Although counseling has been shown to be effective, it is costly and some patients dislike counseling, others have responsibilities that make attendance difficult, and patients in rural settings often have limited access to psychotherapy. Thus, there is a clear need to develop additional acceptable and cost-effective treatments. Interactive Voice Response (IVR) systems, which have been shown to effectively augment brief interventions for substance abuse, are automated, computer-based systems delivered via phone and use voice or keys to access different menus. IVR systems can be accessed from any phone rather than only specified technology (e.g., smartphones), and offer advantages of low cost, consistent delivery, expanded access, and 24-hour availability of immediate therapeutic intervention. The Recovery Line is a Cognitive Behavioral Therapy (CBT)-based IVR system to reduce substance use in patients receiving opioid agonist maintenance. We recently completed a pilot randomized 4-week trial which showed significant reduction in cocaine use and increased coping skill efficacy, but patients called less time than expected, suggesting methods to improve patient use may further improve efficacy. This Stage Ib application proposes three phases to develop system functions to increase patient system use and to test those functions. The initial two phases will develop customized recommendations and reminders to be used in Phase 3 pilot clinical trial. The Phase 3 trial is a 12-week pilot randomized (N=60), clinical trial with a 3 month post-treatment follow-up to obtain data regarding the feasibility, acceptability and efficacy of the developed Recovery Line (compared to TAU). Efficacy will be evaluated for the two primary outcome domains of the proportion of urine screens negative for illicit drugs and monthly days of illicit drug abstinence. Secondary outcome measures will be retention in treatment and coping skills efficacy.
- Conditions
- Drug Dependence, Substance Use Disorders
- Being tested
- Recovery Line
- Keywords
- Opioid Substitution Treatment, Cognitive Behavioral Therapy, Mobile Health
- 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.
Recovery LineBehavioural
Also called Therapeutic interactive voice response, Therapeutic IVR, TIVR
| Study group | Role | What they receive |
|---|---|---|
| Recovery Line plus Treatment-as-Usual (RL+TAU) | Experimental | The Recovery Line is an automated computer-based IVR system that provides CBT-based modules. The RL+TAU condition will include the customized therapeutic recommendations developed in Phase 1, and the contact reminders messages and time frame that maximized system use in Phase 2. Patients will receive an orientation, 24-hour access, encouragement to use the system from clinic staff reminder, and technical assistance line for system problems. Patients will receive 12 weeks of system access. Receives: Behavioral: Recovery Line |
| Treatment-as-Usual | No intervention | Treatment-as Usual involves daily methadone and associated psychosocial services. Patients are required to attend 1 group session per month and are encouraged to attend open drop-in groups available daily covering a range of topics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
urine screens
bi-weekly urine screens negative for illicit drugs
Measured: 6 months
self reported drug use
monthly days of self reported illicit drug abstinence
Measured: 6 months
Secondary outcomes (2)
treatment retention
days retained in methadone treatment
Measured: 6 months
coping behaviors
coping behaviors as measured by the Effectiveness of Coping Behavior Inventory and the Drug Risk Response Test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startNov 2015
- Primary completionApr 2017
- Study completionApr 2017
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 Drug DependenceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- APT Foundation, Inc., National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124980
- Sponsor's protocol ID
- 1208010744
- Other IDs
- R01DA034678
- Status last verified
- Jun 2017
- First submitted
- 24 Apr 2014
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Moore BA, Buono FD, Printz DMB, Lloyd DP, Fiellin DA, Cutter CJ, Schottenfeld RS, Barry DT. Customized recommendations and reminder text messages for automated, computer-based treatment during methadone. Exp Clin Psychopharmacol. 2017 Dec;25(6):485-495. doi: 10.1037/pha0000149.
PubMed 29251978
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Recovery Line for Medication Assisted Treatment
- ClinicalTrials.gov ID
- NCT02124980
- Acronym / sponsor ID
- 1208010744
- Conditions
- Drug Dependence, Substance Use Disorders
- Keywords
- Opioid Substitution Treatment, Cognitive Behavioral Therapy, Mobile Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- APT Foundation, Inc., National Institute on Drug Abuse (NIDA)
- Study start
- Nov 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 28 Apr 2014 (estimated)
- 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.
If shown to be effective, the Recovery Line would provide an inexpensive, transportable, and easy to use treatment to improve substance abuse outcomes for medication assisted treatment. Given the high costs of relapse and continued drug use, improvement of treatment outcomes would provide substantial health, economic, and societal benefits.
Detailed description
Dependence on heroin and prescription pain relievers has almost tripled since 2000, resulting in dramatic increases in opioid dependence treatment admissions. However, among agonist-maintained patients continued drug use is common and associated with high rates of relapse and treatment drop-out. Although counseling has been shown to be effective, it is costly and some patients dislike counseling, others have responsibilities that make attendance difficult, and patients in rural settings often have limited access to psychotherapy. Thus, there is a clear need to develop additional acceptable and cost-effective treatments. Interactive Voice Response (IVR) systems, which have been shown to effectively augment brief interventions for substance abuse, are automated, computer-based systems delivered via phone and use voice or keys to access different menus. IVR systems can be accessed from any phone rather than only specified technology (e.g., smartphones), and offer advantages of low cost, consistent delivery, expanded access, and 24-hour availability of immediate therapeutic intervention. The Recovery Line is a Cognitive Behavioral Therapy (CBT)-based IVR system to reduce substance use in patients receiving opioid agonist maintenance. We recently completed a pilot randomized 4-week trial which showed significant reduction in cocaine use and increased coping skill efficacy, but patients called less time than expected, suggesting methods to improve patient use may further improve efficacy. This Stage Ib application proposes three phases to develop system functions to increase patient system use and to test those functions. The initial two phases will develop customized recommendations and reminders to be used in Phase 3 pilot clinical trial. The Phase 3 trial is a 12-week pilot randomized (N=60), clinical trial with a 3 month post-treatment follow-up to obtain data regarding the feasibility, acceptability and efficacy of the developed Recovery Line (compared to TAU). Efficacy will be evaluated for the two primary outcome domains of the proportion of urine screens negative for illicit drugs and monthly days of illicit drug abstinence. Secondary outcome measures will be retention in treatment and coping skills efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recovery Line plus Treatment-as-Usual (RL+TAU) | Experimental | Behavioral: Recovery LineThe Recovery Line is an automated computer-based IVR system that provides CBT-based modules. The RL+TAU condition will include the customized therapeutic recommendations developed in Phase 1, and the contact reminders messages and time frame that maximized system use in Phase 2. Patients will receive an orientation, 24-hour access, encouragement to use the system from clinic staff reminder, and technical assistance line for system problems. Patients will receive 12 weeks of system access. |
| Treatment-as-Usual | No intervention | –Treatment-as Usual involves daily methadone and associated psychosocial services. Patients are required to attend 1 group session per month and are encouraged to attend open drop-in groups available daily covering a range of topics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- are at least 18 years old
- currently receiving methadone maintenance treatment
- illicit drug use in the past 14 days or a positive urine screen for any tested illicit drug.
Key exclusion criteria (5 listed)
- Current suicide or homicide risk
- meet criteria for Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV current psychotic disorder, or bipolar disorder
- Unable to read or understand English
- Unable to complete the study because of anticipated incarceration or move
- Life-threatening or unstable medical problems.
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 |
|---|---|---|
| Recovery LineAlso: Therapeutic interactive voice response, Therapeutic IVR, TIVR | Behavioural | Recovery Line plus Treatment-as-Usual (RL+TAU) |
Primary outcome
urine screens
Time frame: 6 months
bi-weekly urine screens negative for illicit drugs
self reported drug use
Time frame: 6 months
monthly days of self reported illicit drug abstinence
2 secondary outcomes
treatment retention
Time frame: 6 months
coping behaviors
Time frame: 6 months
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 2 Jul 2017.
- Derived from this study: PubMed 29251978Moore BA, Buono FD, Printz DMB, Lloyd DP, Fiellin DA, Cutter CJ, Schottenfeld RS, Barry DT. Customized recommendations and reminder text messages for automated, computer-based treatment during methadone. Exp Clin Psychopharmacol. 2017 Dec;25(6):485-495. doi: 10.1037/pha0000149.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery Line in people with Drug Dependence and Substance Use Disorders, run by Yale 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 3 inclusion and 5 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 2 Jul 2017. 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?
urine screens (time frame: 6 months). 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 NCT02124980, 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 2 Jul 2017.