Personalized Feedback for Chronic Pain with Substance Use

Overseen By Joseph W. Ditre, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Syracuse University

Must be taking: Opioids

Disqualifiers: Substance use treatment, Psychiatric distress, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new computer-based program designed to assist people with chronic pain who consume alcohol and take prescription opioids. The goal is to help participants understand the risks of mixing alcohol with opioids and to encourage healthier habits. The trial compares two versions of this program: the Pain-Alcohol Personalized Feedback Intervention and the Control Personalized Feedback Intervention, to determine which is more effective. It suits individuals who drink heavily, have chronic pain, and take prescription opioids. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve health outcomes for individuals facing similar challenges.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it focuses on people who are currently prescribed opioids, so it seems likely that you can continue taking them.

What prior data suggests that this personalized feedback intervention is safe for hazardous drinkers with chronic pain?

Research has shown that personalized feedback interventions (PFIs), often delivered through computers, are generally safe. Studies indicate they can help reduce pain and lower problematic alcohol use. These treatments are easy to manage, with few reports of negative effects. Designed to be short and simple, they pose minimal risks for participants. Evidence suggests these interventions have minimal safety concerns for people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pain-Alcohol Personalized Feedback Intervention because it offers a unique approach by focusing on personalized feedback to address both chronic pain and substance use, particularly alcohol. Unlike traditional treatments that might separately target pain with medications like opioids or alcohol use with behavioral therapy, this intervention combines insights from both areas to provide tailored feedback to individuals. This personalized approach has the potential to enhance patient engagement and lead to more effective management of these intertwined conditions.

What evidence suggests that this trial's interventions could be effective for hazardous drinkers with chronic pain?

Research has shown that personalized feedback interventions (PFIs) can improve pain management and reduce risky alcohol use. In this trial, participants will receive one of two PFIs: the Control Personalized Feedback Intervention or the Pain-Alcohol Personalized Feedback Intervention. Studies have found that these computer-based programs effectively lower dangerous drinking and improve the lives of people with chronic pain. PFIs provide customized advice that boosts motivation to change drinking habits and discourages mixing alcohol with opioids. This method shows promise for those dealing with both chronic pain and risky drinking, as it addresses their specific challenges. Overall, early evidence suggests that PFIs could be a helpful strategy for managing these complex issues. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 21 with chronic pain who drink alcohol hazardously and are currently using prescription opioids. It's not for those who don't speak English, have severe mental health issues, or are already in treatment for substance use.

Inclusion Criteria

I am currently taking prescription opioid medications.

You currently drink alcohol in a way that is risky for your health.

I am 21 years old or older.

Exclusion Criteria

I am not fluent in English.

You are currently experiencing severe mental distress or confusion.

You are currently receiving treatment for alcohol or other substance use.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase IA - Intervention Development

Collecting qualitative and quantitative feedback from focus groups to refine intervention content and evaluate treatment acceptability and feasibility

Not specified

Phase IB - Randomized Clinical Trial

Proof-of-concept trial comparing PA-PFI to control PFI among hazardous drinkers with chronic pain

3 months

Baseline and immediately after intervention

Follow-up

Participants are monitored for changes in alcohol-opioid co-use, motivation to reduce drinking, and other outcomes

3 months

3 month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Control Personalized Feedback Intervention
• Pain-Alcohol Personalized Feedback Intervention

Trial Overview The study tests a computer-based feedback program designed to educate about the risks of mixing alcohol with opioid medications and motivate a reduction in hazardous drinking among chronic pain patients.

How Is the Trial Designed?

Group I: Pain-Alcohol Personalized Feedback Intervention Experimental Treatment 1 Intervention

Group II: Control Personalized Feedback Intervention Active Control 1 Intervention

Who Is Running the Clinical Trial?

Syracuse University

Lead Sponsor

Trials

54

Recruited

118,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

The pilot study involving 10 adults initiating buprenorphine treatment showed that a web- and text message-based intervention was highly acceptable, with 100% engagement from participants over 8 weeks and a high satisfaction score of 27 out of 30.

Participants reported positive experiences and clinical improvements, suggesting that this digital health intervention could effectively enhance motivation and distress tolerance, potentially leading to better treatment adherence and reduced opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing distress tolerance to uplift motivation in recovery: Results from an open development trial. Bhuptani, PH., Block, A., Jiménez Muñoz, P., et al.[2023]

In a pilot study involving 60 adults with chronic pain and opioid use disorder, participants who used an online pain self-management program reported significant reductions in pain interference, pain severity, opioid misuse, and depressive symptoms after 8 weeks.

The study highlights that a majority of participants initially used opioids due to pain, indicating that effective pain management strategies like this online program could be crucial in addressing both pain and opioid misuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement in online pain self-management improves pain in adults on medication-assisted behavioral treatment for opioid use disorders. Wilson, M., Finlay, M., Orr, M., et al.[2019]

Personalized feedback interventions (PFIs) have been found to effectively improve pain outcomes and reduce problematic alcohol consumption, suggesting a beneficial approach for individuals experiencing both issues.

The review highlights the potential for developing integrated, computer-based PFIs that address both pain and alcohol misuse, which could ease the burden on patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An integrative review of personalized feedback interventions for pain and alcohol. Powers, JM., Zvolensky, MJ., Ditre, JW.[2020]

A new five-item measure called Expectancies for Alcohol Analgesia (EAA) was developed to assess how likely people believe alcohol is to relieve their pain, showing strong reliability and validity in a study of 273 chronic pain patients.

The EAA scores were significantly linked to higher alcohol use and pain severity, suggesting that beliefs about alcohol's pain-relieving effects may influence drinking behavior among those with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A measure of expectancies for alcohol analgesia: Preliminary factor analysis, reliability, and validity. LaRowe, LR., Maisto, SA., Ditre, JW.[2022]

A study involving 24 adults in outpatient buprenorphine treatment found that a computer- and text message-based intervention is highly acceptable and can effectively support recovery by reducing stigma and enhancing learning.

Participants preferred a personalized intervention that includes both automatic and on-demand text messages, suggesting that incorporating multimedia elements could further improve engagement and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a digital health intervention to promote engagement in and adherence to medication for opioid use disorder. Langdon, KJ., Scherzer, C., Ramsey, S., et al.[2023]

In a study involving 121 participants from a community substance use disorder clinic, personalized feedback interventions did not show any significant benefits in reducing alcohol consumption compared to standard pre-treatment assessment procedures.

The results indicated that feedback-based brief interventions were ineffective in improving outcomes such as drinking frequency, intensity, or motivation for treatment among individuals with substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Feedback-Based Brief Intervention to Reduce Alcohol Use in Community Substance Use Disorders. Worden, BL., McCrady, BS.[2021]

In a study of 451 treatment-seeking alcoholics, significant recurrent pain was found in over half (53.66%) of participants, with a higher prevalence in women (62.57%) compared to men (47.35%).

Participants with pain reported greater levels of depression and anxiety, and their pain severity was linked to delays in receiving treatment for alcohol dependence, emphasizing the need for effective pain management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing chronic pain and alcohol use trajectory among treatment-seeking alcoholics. Boissoneault, J., Lewis, B., Nixon, SJ.[2020]

In a study involving 58 participants over a 10-week trial of the Pain EASE program, individuals reported using more pain self-management modules than what was actually observed in the program's log data.

Participants accessed less than half of the modules that were specifically recommended to them, highlighting a gap between self-reported engagement and actual usage of tailored internet-based interventions for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

If you personalize it, will they use it?: Self-reported and observed use of a tailored, internet-based pain self-management program. Reuman, L., Solar, C., MacLean, RR., et al.[2023]

In a study involving 2125 participants from two clinical trials, pain was found to significantly predict lapses in heavy drinking during and after treatment for alcohol use disorders, indicating that individuals in pain are at a higher risk of relapse.

Specifically, pain was a strong predictor of heavy drinking lapses both during treatment (odds ratio of 1.19 in the UKATT and 1.12 in the COMBINE study) and after treatment (odds ratio of 1.44 in the COMBINE study), even when controlling for other relapse risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain as a predictor of heavy drinking and any drinking lapses in the COMBINE study and the UK Alcohol Treatment Trial. Witkiewitz, K., Vowles, KE., McCallion, E., et al.[2022]

Individuals who consume higher amounts of alcohol are more likely to choose to receive personalized feedback about their drinking habits, with 85% of participants consistently opting in across two time points.

Receiving feedback led to a small reduction in peak alcohol consumption among heavy drinkers over a 30-day period, suggesting that personalized interventions may help reduce drinking intensity, although further research is needed to confirm these findings in more diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Who Opts In to Alcohol Feedback and How Does That Impact Behavior? A Pilot Trial. Boness, CL., Helle, AC., Miller, MB., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6667314/

An Integrative Review of Personalized Feedback ... Our review of the literature revealed that brief, computer-based PFIs can improve pain outcomes and decrease problematic alcohol consumption.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11533922/

Development of a Personalized Feedback Intervention ... Among individuals with chronic pain, the rate of hazardous alcohol use is elevated compared with the general population. Yet, hazardous drinkers with ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352250X1830263X

An integrative review of personalized feedback ... Future work is needed to adapt brief and portable interventions for adult drinkers with chronic pain. Interrelations between pain and alcohol consumption are ...

4. withpower.com withpower.com/trial/personalized-feedback-for-chronic-pain-with-substance-use-a0207

Personalized Feedback for Chronic Pain with Substance Use Personalized feedback interventions (PFIs) have been found to effectively improve pain outcomes and reduce problematic alcohol consumption, suggesting a ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05036499?tab=history&a=2

Record History | ver. 2: 2021-09-27 | NCT05036499 Experimental: Personalized Feedback Intervention (PFI). Personalized Feedback Intervention targeting pain-related anxiety for hazardous drinkers with chronic ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871624000425

Mobile health intervention to address chronic pain among ... The purpose of this study was to develop a novel, integrated mobile health intervention that improves pain management and reduces hazardous drinking.

7. issup.net issup.net/knowledge-share/resources/2024-10/development-personalized-feedback-intervention-targeting-pain

Development of a Personalized Feedback Intervention ... Individuals with chronic pain are more likely to engage in hazardous alcohol use compared to the general population.