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Just-In-Time Adaptive Interventions for Addictive Behaviors

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ClinicalTrials.gov Identifier: NCT03538652
Recruitment Status : Not yet recruiting
First Posted : May 28, 2018
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) )

Brief Summary:

Background:

Many smartphone apps intend to help people with addictions. But not enough is known about how they should work. Researchers want to study an app that gives people the advice they need, just when they need it. This is a JITAI. It stands for Just-In-Time Adaptive Intervention. To create a good JITAI, researchers need to know what approaches work best at different moments.

Objective:

To develop ways to treat addiction with a smartphone app.

Eligibility:

Adults ages 18-75 who use heroin or other opioids

Design:

Participants will be screened in another protocol.

Participants will visit a Baltimore clinic 3 days a week to give urine and breath samples.

Some participants will get their treatment at this clinic.

Participants will answer questions about their personality and stress.

Participants will randomly be assigned to the JITAI group or a comparison group.

Participants will have a training session on using the smartphone app. JITAI participants will also watch a video about the written messages they ll see in the app.

Weeks 3-10: participants will carry a smartphone. Four times a day, it will beep and ask questions. These will be about the participant s activities and mood. The JITAI group will see a short message after. The message is meant to be helpful.

For the first 16 evenings, JITAI participants will get more information on the phone.

Answers to the app s questions will be transferred automatically from the smartphone to secure computers at the NIH.

During the last week, participants can choose the kind of messages they see.

Week 11: participants will return the smartphone and answer questions.

Weeks 12-16, participants who are getting their medicine from the research clinic will be encouraged to transfer to other clinics. Otherwise, they will have their dose slowly reduced to zero.


Condition or disease Intervention/treatment Phase
Drug Dependence Behavioral: JITAI Behavioral: Placebo Comparator Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Just-In-Time Adaptive Interventions for Addictive Behaviors
Estimated Study Start Date : March 29, 2019
Estimated Primary Completion Date : December 12, 2020
Estimated Study Completion Date : December 12, 2021

Arm Intervention/treatment
No Intervention: Formative Interviews
First stage, before content of mobile intervention is finalized
Active Comparator: JITAI
Group receiving microrandomized active intervention: JITAI with both CBT and ACT
Behavioral: JITAI
Just-In-Time Adaptive Intervention delivered via smartphone app

Placebo Comparator: EMA only
Randomized control group undergoing mobile assessment without JITAI
Behavioral: Placebo Comparator
Randomized control group undergoing mobile assessment without JITAI




Primary Outcome Measures :
  1. Strategy-situation fit [ Time Frame: 20 minutes ]
  2. Distal effects of JITAI on self-efficacy and coping flexibility [ Time Frame: 9 weeks ]
  3. Proximal effects of CBT and ACT messages in a JITAI [ Time Frame: 20 minutes ]

Secondary Outcome Measures :
  1. Whether the intervention types that benefit participants most when the same ones participants choose when subsequently given the opportunity to interventions [ Time Frame: 9 weeks ]
  2. Time courses of responsiveness to ACT vs. CBT, in the JITAI group [ Time Frame: 9 weeks ]
  3. Group differences in frequency of opioid-positive urine over time [ Time Frame: 9 weeks ]
  4. Trait predictors of differential responses to CBT and ACT [ Time Frame: 9 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Phase 1: Formative interviews.

The enrollment ceiling is 25 outpatients (to collect evaluable data from 20) who meet these criteria: (1) Age 18-75; (2) physical dependence on opioids (by self-report); (3) interest in receiving the types of treatment about which we will be conducting interviews.

Phase 2: Clinical trial with microrandomization.

The enrollment ceiling is 150 outpatients (to collect evaluable data from 85, of whom 50 will be randomized to JITAI, and 35 to EMA control). Treatment may be provided by us in the form of office-based buprenorphine treatment (OBOT) or may be provided elsewhere (Treatment Elsewhere, TE). Participants must meet these criteria:

OBOT participants: (1) Age 18-75; (2) physical dependence on opioids (by positive urine and/or frank opioid withdrawal); (3) interest in receiving the types of treatment we are testing.

Treatment Elsewhere (TE) participants: (1) Age 18-75; (2) receiving methadone or buprenorphine treatment for opioid dependence from a qualified provider in the community; (3) interest in receiving the types of treatment we are testing.

EXCLUSION CRITERIA:

Phase 1: Formative interviews. (1) cognitive impairment severe enough to preclude informed consent or valid interview responses.

Phase 2: Clinical trial with microrandomization.

OBOT participants: (1) History of any DSM-V psychotic disorder; history of bipolar disorder; current Major Depressive Disorder; (2) unresolved symptoms of PTSD that, in the investigators view, would make it risky for the participant to undertake mindfulness exercises (e.g., observing all one s current negative thoughts and emotions) in an unsupervised setting; (3) current dependence on alcohol or sedative-hypnotic, e.g. benzodiazepine (by DSM-V criteria); (4) cognitive impairment severe enough to preclude informed consent or valid self-report; (5) Any condition that interferes with urine collection; (6) medical illness (e.g., cirrhosis, nephritic syndrome, thyroid disease, ischemic heart disease, epilepsy, adrenal insufficiency, etc.) or medications that, in the view of the investigators, would compromise participation in research.

Treatment Elsewhere (TE) participants: (1) History of any DSM-V psychotic disorder; history of bipolar disorder; current Major Depressive Disorder; (2) unresolved symptoms of PTSD that, in the investigators view, would make it risky for the participant to undertake mindfulness exercises (e.g., observing all one s current negative thoughts and emotions) in an unsupervised setting; (4) current dependence on alcohol or sedative-hypnotic, e.g. benzodiazepine (by DSM-V criteria); (5) cognitive impairment severe enough to preclude informed consent or valid self-report; (6) Any condition that interferes with urine collection; (6) medical illness (e.g., cirrhosis, nephritic syndrome, thyroid disease, ischemic heart disease, epilepsy, adrenal insufficiency, etc.) or medications that, in the view of the investigators, would compromise participation in research.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538652


Contacts
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Contact: David H Epstein, Ph.D. (443) 740-2328 depstein@intra.nida.nih.gov

Locations
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United States, Maryland
National Institute on Drug Abuse Not yet recruiting
Baltimore, Maryland, United States, 21224
Contact: David Epstein, Ph.D.    443-740-2328    depstein@intra.nida.nih.gov   
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: David H Epstein, Ph.D. National Institute on Drug Abuse (NIDA)

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Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT03538652     History of Changes
Other Study ID Numbers: 999918095
18-DA-N095
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: June 6, 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) ):
CBT
Mindfulness
Opiates
Ecological Monetary Assessment (EMA)
Microrandomized Trial

Additional relevant MeSH terms:
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Substance-Related Disorders
Behavior, Addictive
Chemically-Induced Disorders
Mental Disorders
Compulsive Behavior
Impulsive Behavior