What side effects are associated with this type of intervention?

Common treatments for Opioid Use Disorder (OUD) include methadone, buprenorphine, and cognitive-behavioral therapy (CBT). Methadone and buprenorphine can cause side effects such as constipation, nausea, vomiting, sedation, and respiratory depression. CBT, which is often used alongside these medications, generally has fewer physical side effects but may cause emotional discomfort as patients work through their issues. Combining these treatments with self-management and education, as in the STAMP+CBT app, aims to mitigate these side effects by providing tailored advice and support.

What prior FDA approvals exist?

The FDA has approved several treatments for opioid use disorder, including medications like buprenorphine, methadone, and naltrexone. Buprenorphine, often combined with naloxone, is used to reduce opioid cravings and withdrawal symptoms. Methadone is a long-acting opioid agonist that helps prevent withdrawal and reduce cravings. Naltrexone is an opioid antagonist that blocks the effects of opioids. These treatments are often combined with psychosocial interventions, such as cognitive-behavioral therapy (CBT), to enhance their effectiveness. The STAMP+CBT app's approach of tracking pain, mood, opioid use, and side effects while delivering tailored education and self-management advice aligns well with these comprehensive treatment strategies.

What other types of research exist?

Promising alternatives to the STAMP+CBT app for OUD patients include: 1) Mobile apps like QuitGuide and quitSTART, which offer tracking, motivational messaging, and coping strategies. 2) Digital platforms leveraging social networks (e.g., Twitter, Facebook, Whatsapp) for smoking cessation, which have shown potential in helping users quit and avoid relapse. 3) Web-based and telephone counseling interventions, which may offer more personalized support compared to mobile apps. These alternatives provide comprehensive support and monitoring, similar to STAMP+CBT, and are worth considering for OUD treatment in 2024.

← Back to Search

Cognitive Behavioral Therapy App for Cancer Pain (STAMP+CBT Trial)

N/A

Recruiting

Led By Desiree Azizoddin, PsyD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has an active prescription for at least one opioid medication to treat their cancer pain (i.e. not for post-surgical pain)

Chronic pain related to cancer or treatment (> pain score of 4)

Must not have

Currently hospitalized

Adults who are unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the STAMP+CBT app, a smartphone tool for advanced cancer patients to manage pain and mood. It tracks health metrics and provides personalized advice and educational content to improve pain management.

Who is the study for?

This trial is for adults over 18 with advanced cancer experiencing chronic pain (pain score >4) and using opioids to manage it. They must be undergoing treatment or receiving supportive care, not in remission, hospice, or hospitalized. Excludes those with cognitive impairments affecting participation, non-English speakers, recent surgery patients, and individuals under opioid risk mitigation programs.

What is being tested?

The study tests a new smartphone app called STAMP+CBT designed to help track pain levels, mood changes, opioid use and side effects while providing personalized education and self-management tips for managing cancer-related pain.

What are the potential side effects?

Since this intervention involves Cognitive Behavioral Therapy via an app rather than medication or invasive procedures, the side effects are minimal but may include discomfort from confronting painful emotions or stress related to tracking one's condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am currently prescribed opioids for my cancer pain.

Select...

My cancer or its treatment causes me significant pain.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently in the hospital.

Select...

I am an adult capable of giving consent, not pregnant, and not incarcerated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients who complete more than 2/3rd of the study modules at the end of 4 weeks of intervention to determine feasibility of the STAMP+CBT app

Proportion of patients who rate the acceptability items 4 or higher on the app.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: STAMP+CBT appExperimental Treatment1 Intervention

This app will allow the patient to access daily surveys designed to assess pain, stress, mood, and related symptoms. Based on patient-reported symptoms, this app will disseminate tailored education to manage the symptoms.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Opioid Use Disorder (OUD) include pharmacological and psychological interventions. Medications like methadone and buprenorphine bind to opioid receptors in the brain, reducing cravings and withdrawal symptoms without producing a high, while naltrexone blocks these receptors to prevent euphoria from opioid use. Psychological treatments such as Cognitive Behavioral Therapy (CBT) and Motivational Interviewing (MI) focus on changing behaviors and thought patterns related to substance use. These treatments are essential for OUD patients as they address both physical dependence and psychological factors, enhancing overall treatment effectiveness. The STAMP+CBT app exemplifies an integrated approach by tracking pain, mood, opioid use, and side effects, while delivering tailored education and self-management advice.

Systematic review on the clinical management of chronic pain and comorbid opioid use disorder.Opioid use by patients in an orthopedics spine clinic.