Smartphone app for Opioid Abuse

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
NYU Langone, New York, NY
Opioid Abuse+1 More
Smartphone app - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a brief intervention can reduce the likelihood of illicit opiate use in people with opioid addiction.

See full description

Eligible Conditions

  • Opioid Abuse
  • Opioid Use Disorder (OUD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Smartphone app will improve 1 primary outcome and 1 secondary outcome in patients with Opioid Abuse. Measurement will happen over the course of 1 month visit, 3 months visit, 6 months visit.

Month 6
Proportion of patients will reduce illicit substance reuse rates with PREDICTIVE-DOSING relative to treatment as usual (TAU).
To assess the impact of POSTUSE-DOSING on reuse rates relative to TAU

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

5 Treatment Groups

Treatment-as-Usual
1 of 5
Smartphone with dose changes before using
1 of 5
Smartphone with dose changes after using
1 of 5
Focus group with Study Physicans
1 of 5
Focus group with Clinicians
1 of 5
Active Control
Experimental Treatment

This trial requires 510 total participants across 5 different treatment groups

This trial involves 5 different treatments. Smartphone App is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Smartphone with dose changes before using
Other
Participants will have an app installed on their phone and have to complete a brief questionnaire and some days to play a 2-4 minute game.
Smartphone with dose changes after using
Other
Participants will have an app installed on their phone and have to complete a brief questionnaire and some days play a 2-4 minute game.
Focus group with Study Physicans
Other
Study physicians asked to participate in a focus group session or 1:1 interviews if unable to attend the focus group during year one of the study and once annually towards the end of years 2, 3, 4, and 5 of the study
Focus group with Clinicians
Other
Clinicians asked to participate in a 1:1 interview and a separate focus group at roughly the same time. Prior to the first structured interview with our study team, you will participate in a 1-hour training and familiarization session with the SOAR system using synthetic or training data.
Treatment-as-UsualParticipants will receive the same treatment as if they had not joined the study

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month visit, 3 months visit, 6 months visit
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 month visit, 3 months visit, 6 months visit for reporting.

Closest Location

NYU Langone - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Opioid Abuse or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Licensed MD employed by the respective site, or at a clinical partner of the respective site, where they will act as participants and be part of the treatment team
Meet DSM-5 criteria for opioid-use disorder (heroin and/or prescription opioids);
Have entered, or expressed a clear intention to enter, an OUD treatment program that prescribes either methadone or buprenorphine
Any gender;
18 years of age and older;
Have used opioids other than as specifically prescribed within thirty days prior to consent;
In good-enough general health;
Capacity to provide written informed consent as assessed by our Subject Comprehension Assessment Tool(subjects lacking the ability to consent will not be enrolled) ;
Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.
Study-Physician Participants.

Patient Q&A Section

What are the common side effects of smartphone app?

"The survey found common side effects of smartphone app, such as: question: Do common patient characteristics predict the use of smartphone apps? answer: Patient characteristics were the primary predictors of use of smartphone apps, however, use of other technology was important for the total percentage of smartphone app use." - Anonymous Online Contributor

Unverified Answer

What are common treatments for opioid abuse?

"Most of the medications are used to reduce the negative and positive signs and symptoms associated with opioid withdrawal. In general, most of the medications are used to treat other acute illnesses and do not treat opioid dependence in and of itself. Several treatments or therapies can reduce the number of drugs needed but the long-term benefits of such reductions remain uncertain. Many addiction treatment programs have a strong emphasis on recovery through the use of 12-step treatment and supportive housing. These programs have been shown experimentally to be successful in promoting abstinence but not in reducing relapse rates. A number of medications have been used experimentally in opioid maintenance trials, but none has attracted widespread interest." - Anonymous Online Contributor

Unverified Answer

What are the signs of opioid abuse?

"Results from a recent clinical trial [of our study] indicate that more than one-third of the respondents reported using opioids at least once a week to relieve pain or to make them feel more energetic and alert, and more than one-fourth said they made at least one new medication to get rid of opioids. The study shows that there are important signs and symptoms among drug abusers and their family members to be screened and that a proper medical and medical social follow-up is essential." - Anonymous Online Contributor

Unverified Answer

What causes opioid abuse?

"Abuse of opiates arises from a wide variety of causes. Substance abuse in particular, and particularly the abuse of heroin, plays an important role, and may be the most important factor to investigate in the risk assessment of heroin addiction." - Anonymous Online Contributor

Unverified Answer

What is opioid abuse?

"OA represents a significant public health issue in Canada. The high rate which we have identified warrants additional attention to the consequences of this chronic, insidious disease and the need to prevent it in the future." - Anonymous Online Contributor

Unverified Answer

Can opioid abuse be cured?

"Opioid abuse can be cured in a small subset of individuals. This may be accomplished with the support of peers and family members, and the use of naltrexone. It is possible to reverse tolerance to the therapeutic effects of opioids by using methadone and/or buprenorphine." - Anonymous Online Contributor

Unverified Answer

How many people get opioid abuse a year in the United States?

"The numbers, by and large, are similar to the yearly rates for alcohol or tobacco abuse. It is estimated that 5-6 million people in the United States misuse opioids each year. A large portion of these people could benefit from treatment." - Anonymous Online Contributor

Unverified Answer

Is smartphone app typically used in combination with any other treatments?

"Data from a recent study shows the value of using smartphone apps in conjunction to traditional medical-treatment regimes and demonstrates that smartphones can serve as effective and non-invasive means of improving patient outcomes." - Anonymous Online Contributor

Unverified Answer

How does smartphone app work?

"The smartphone app was able to reliably and accurately detect opioid use, and was successful in assisting patients seeking help with detoxification. The smartphone app was well received by patients and providers." - Anonymous Online Contributor

Unverified Answer

Is smartphone app safe for people?

"The majority of app assessments assessed were favorable or positive. Recent findings raise concern about whether smartphone apps are safe for medical practice and warrant further study. Additional research is needed to evaluate potential harms associated with and barriers to smartphone app use with patients and healthcare professionals who routinely use mobile technology for assessment and care delivery in practice." - Anonymous Online Contributor

Unverified Answer

What is the latest research for opioid abuse?

"Current research has revealed several approaches to preventing or treating opioid abuse. While these approaches aim to alter opioid pharmacology, they do not prevent the development and continuing use of opioid addiction and the problems related to it. Current studies are needed to better understand what causes the initiation and maintenance of opioid use, the development of opioid dependence, the progression of opioid abuse to addiction, the neurobiology and treatment of opioid abuse, and the underlying neural substrate of addiction. Improved knowledge about the etiology of opioid abuse and the neuroscience underlying the biology of addiction should lead to better treatment protocols for opioid use and abuse." - Anonymous Online Contributor

Unverified Answer

Does opioid abuse run in families?

"Results suggest that while opioid abuse is linked to a number of familial diseases, it does not run in families. However, as for many other rare disorders, some aspects of family history may indicate that family members of an opioid drug abuser may be at increased risk, perhaps due to problems with liver metabolism of the drug." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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