Cognitive-Behavioral Therapy for Opioid Use Disorder

Overseen By Lisham Ashrafioun, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: No phone, No internet, others

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

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different therapies can help people with opioid use disorder feel less lonely. Participants will divide into three groups: one receiving Cognitive-Behavioral Therapy (CBT) through telehealth, another using self-guided health education, and the last receiving health education from a therapist via telehealth. Each group attends six weekly sessions, each lasting around 45 minutes. Individuals with opioid use disorder who often feel lonely or disconnected might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to explore innovative therapies that could enhance well-being and reduce loneliness.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive-Behavioral Therapy (CBT) is generally safe for people. It is a common treatment for mental health issues like anxiety and depression. Studies indicate that most people handle CBT well, typically without negative side effects. No specific evidence shows harm from this therapy. CBT focuses on changing negative thoughts and behaviors, which is unlikely to cause physical harm.

In this study, the therapy is delivered through telehealth, which also has a good safety record. Previous patients found this method manageable and helpful. Overall, CBT appears to be a safe option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore innovative approaches to tackling opioid use disorder (OUD) through telehealth. Unlike standard treatments like medication-assisted therapies (e.g., methadone, buprenorphine) that focus on the physiological aspects of addiction, cognitive-behavioral therapy (CBT) targets the psychological component by addressing perceived social isolation, which can be pivotal in recovery. This CBT is delivered via telehealth, making it accessible and convenient for individuals who may struggle with attending in-person sessions. Additionally, the trial includes both self-guided and therapist-delivered health education, offering flexibility and potentially empowering patients to take an active role in their recovery. These features could make treatment more personalized and widely available, especially for those in remote or underserved areas.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Research has shown that Cognitive-Behavioral Therapy (CBT), which participants in this trial may receive, can help treat opioid use disorder by reducing feelings of loneliness and social isolation. One study found that addressing these feelings led to less opioid misuse. Another study confirmed this by demonstrating that patients improved their social connections and reduced their opioid use. This therapy not only helps change harmful thoughts and behaviors but also aims to build a supportive social network. By focusing on both mental and social aspects, CBT offers a promising approach for those struggling with opioid use disorder. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who understand English, have internet access, and are experiencing both opioid use disorder and feelings of loneliness or disconnection.

Inclusion Criteria

I understand English and have internet access.

I feel very lonely often.

I have been diagnosed with an opioid addiction.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three interventions: therapist-delivered cognitive-behavioral therapy, therapist-delivered health education, or self-guided health education over 6 weekly sessions

6 weeks

6 visits (virtual for therapist-delivered sessions)

Follow-up

Participants are monitored for changes in loneliness, opioid use, social interactions, and mental health factors

6 months

Assessments at 1, 3, and 6 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive-Behavioral Therapy for Perceived Social Isolation
• Health Education

Trial Overview The study tests Cognitive-Behavioral Therapy aimed at reducing perceived social isolation versus Health Education. Participants will be divided into three groups receiving weekly sessions for six weeks.

How Is the Trial Designed?

Group I: Cognitive-Behavioral Therapy Experimental Treatment 1 Intervention

CBT delivered over the course of 6, \~45 minute sessions delivered via telehealth

Group II: self-guided Health Education Active Control 1 Intervention

Health education sessions that are self-guided over the course of 6 sessions

Group III: therapist-delivered Health Education Active Control 1 Intervention

Health education sessions delivered over the course of 6, \~45 minute sessions delivered via telehealth.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

The study involved interviews with 14 individuals undergoing intensive outpatient treatment (IOT) for opioid use disorder (OUD), revealing that the process of connecting and disconnecting is crucial to their recovery experience.

Participants emphasized the importance of building connections with the IOT program, fellow patients, and staff, suggesting that fostering these relationships can significantly enhance engagement and support successful recovery from OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Connecting and disconnecting: Experiences of people with opioid use disorder in intensive outpatient treatment. Keen, A., Lu, Y., Draucker, CB.[2022]

In a study of 371 adults receiving methadone maintenance treatment for opioid use disorder, severe loneliness was found to significantly increase the likelihood of illicit opioid use among women, with an odds ratio of 3.00, while it decreased the likelihood among men, with an odds ratio of 0.35.

The findings suggest that addressing loneliness in treatment plans could improve recovery outcomes for patients with opioid use disorder, highlighting the need for strategies that foster social connections in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Loneliness and Illicit Opioid Use Among Methadone Maintenance Treatment Patients. Polenick, CA., Cotton, BP., Bryson, WC., et al.[2020]

Both Resource-oriented cognitive-behavioral therapy (ROCBT) and cognitive therapy (CT) are effective treatments for social anxiety disorder, with treatment gains maintained over a 2-year follow-up period involving 51 patients.

At the 10-year follow-up with 27 patients, significant improvements were observed in social anxiety measures, indicating that both therapies provide durable benefits over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychotherapy for social anxiety disorder: long-term effectiveness of resource-oriented cognitive-behavioral therapy and cognitive therapy in social anxiety disorder. Willutzki, U., Teismann, T., Schulte, D.[2018]

A manualized cognitive-behavioral therapy (CBT) treatment for social anxiety disorder (SAD) was implemented in a case study of a 26-year-old male, resulting in complete remission of his symptoms after 15 sessions.

Follow-up assessments at 2 and 8 months post-treatment showed that the remission of SAD symptoms was maintained, highlighting the long-term efficacy of this CBT approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manualized Cognitive-Behavioral Treatment of Social Anxiety Disorder: A Case Study. Shorey, RC., Stuart, GL.[2021]

A study of 121 mental health care professionals in Saudi Arabia revealed a significant lack of knowledge about computerized cognitive behavioral therapy (cCBT), despite a positive attitude towards its use in therapy.

Most participants believed in the efficacy of cCBT and felt comfortable using computers, indicating a readiness for further education and training in this area to improve mental health treatment accessibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perception of Mental Health Care Professionals in Saudi Arabia on Computerized Cognitive Behavioral Therapy: Observational Cross-sectional Study. AlHadi, AN., Alammari, KA., Alsiwat, LJ., et al.[2021]

A study involving 31 participants with experience in opioid use disorder treatment found that a mobile app designed for telehealth delivery of treatment was rated highly for usability, with participants appreciating its flexibility and helpful features.

Participants not only found the current app features useful but also expressed enthusiasm for proposed additions like daily affirmations and medication reminders, indicating that such technology could help overcome barriers to treatment and support long-term recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient evaluation of a smartphone application for telehealth care of opioid use disorder. Bosse, JD., Hoffman, K., Wiest, K., et al.[2022]

Patients with cancer are living longer, highlighting the need for diverse psychosocial interventions to support their mental and emotional well-being.

The review identifies four common types of interventions—education, behavioral training, individual psychotherapy, and group interventions—each offering potential psychological and physical health benefits for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical review of psychosocial interventions in cancer care. Fawzy, FI., Fawzy, NW., Arndt, LA., et al.[2022]

Psychological issues are common among cancer patients, and while adjuvant psychological therapy (APT) is recognized, there is limited research on the effectiveness of cognitive behavior therapy (CBT) specifically for this group.

CBT can be adapted for cancer patients, addressing unique emotional responses and vulnerabilities, and may help in preventing relapse of psychological issues, highlighting the need for tailored therapeutic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer, emotional responses and cognitive behavioural psychotherapy. Farrington, A.[2019]

Mental health professionals believe that key components of cognitive-behavioral therapy (CBT) for treating opioid use disorder (OUD) include building a strong treatment alliance, teaching coping skills, and using motivational interviewing, which were rated as the most effective strategies.

To enhance the effectiveness of CBT for OUD, professionals suggested incorporating mindfulness practices, peer support, and strategies for medication adherence, while also emphasizing the importance of addressing co-occurring mental health issues and life stressors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mental health professional survey of cognitive-behavioral therapy for the treatment of opioid use disorder. Lent, MR., Callahan, HR., Womer, P., et al.[2021]

A tailored internet-delivered cognitive behavioral therapy (ICBT) program for Canadian public safety personnel (N=83) resulted in large reductions in depression and anxiety symptoms, and moderate reductions in PTSD symptoms after 8 weeks of treatment.

Most participants who initially reported high levels of depression, anxiety, and PTSD experienced clinically significant symptom improvements, indicating that ICBT is a promising treatment option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Outcomes of Transdiagnostic Internet-Delivered Cognitive Behavioral Therapy Tailored to Public Safety Personnel: Longitudinal Observational Study. Hadjistavropoulos, HD., McCall, HC., Thiessen, DL., et al.[2021]

Group cognitive behavioural therapy (CBT) has been shown to effectively address significant and long-term psychosocial problems in cancer patients, including those with advanced disease.

The article emphasizes the importance of time-limited interventions and provides guidance for health workers on how to implement group CBT techniques to support emotionally distressed cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group cognitive behavioural therapy: an intervention for cancer patients. Bottomley, A.[2019]

In a study of 82 patients undergoing treatment for opioid use disorder with buprenorphine, 40.3% tested positive for non-prescribed opioids, indicating a significant issue of illicit opioid use among this population.

Higher levels of loneliness were linked to an increased likelihood of using non-prescribed opioids, suggesting that loneliness may be a risk factor for treatment failure in patients with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association of Loneliness and Non-prescribed Opioid Use in Patients With Opioid Use Disorder. McDonagh, J., Williams, CB., Oldfield, BJ., et al.[2021]

Cognitive-behavioral therapy (CBT) is based on scientific experimentation rather than just theories, making it a unique and evidence-based approach to treatment.

Recent research at the University of Minnesota has integrated new neuroscientific findings with CBT, potentially enhancing its effectiveness and understanding in therapeutic practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of cognitive-behavioral therapy in the University of Minnesota's outpatient psychiatry clinic. Kushner, MG.[2018]

A systematic review of 35 studies, including 30 randomized controlled trials, found that internet-based support interventions can positively impact the quality of life and physical health of breast cancer patients.

However, the effectiveness of these interventions in reducing psychological distress, anxiety, and depression was inconsistent, highlighting the need for more rigorous research to better understand their overall impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-based support interventions on patients with breast cancer: a systematic review and narrative synthesis. Huang, Y., Li, Q., Zhou, F., et al.[2022]

A new conceptual framework was developed to help psychosocial care providers implement evidence-based psychological treatments (EBTs) for cancer patients, based on qualitative data from 125 trainees across two phases of training and support.

The framework emphasizes the importance of both personal factors (like attitudes and behaviors) and environmental factors (such as resources and organizational support) in overcoming implementation challenges, suggesting that improving personal support can help address resource limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing evidence-based psychological treatments for cancer patients. Williams, KC., Brothers, BM., Ryba, MM., et al.[2022]

Citations

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A randomized clinical trial to assess feasibility, acceptability ... The purpose of this study was to report on feasibility, acceptability, and initial efficacy data cognitive-behavioral therapy for perceived isolation (CBT-PSI)

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871624001893

A randomized clinical trial to assess feasibility ... The purpose of this study was to report on feasibility, acceptability, and initial efficacy data cognitive-behavioral therapy for perceived isolation (CBT-PSI)

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11088495/

A randomized clinical trial to assess feasibility, acceptability ... The purpose of this study was to report on feasibility, acceptability, and initial efficacy data cognitive-behavioral therapy for perceived ...

4. ascpjournal.biomedcentral.com ascpjournal.biomedcentral.com/articles/10.1186/s13722-024-00498-y

Comparing cognitive behavioral therapy and social ... The overall objective of our study is to reduce opioid misuse and opioid use disorder by addressing loneliness in patients on long-term opioid therapy.

5. withpower.com withpower.com/trial/phase-social-isolation-6-2024-3d702

Cognitive-Behavioral Therapy for Opioid Use Disorder This treatment is unique because it combines cognitive-behavioral therapy (CBT) with a focus on reducing loneliness and social isolation, which are factors ...

6. researchgate.net researchgate.net/publication/378997637_A_randomized_clinical_trial_to_assess_feasibility_acceptability_and_preliminary_effects_of_telehealth-delivered_cognitive-behavioral_therapy_for_perceived_social_isolation_among_individuals_with_opioi

A randomized clinical trial to assess feasibility ... A randomized clinical trial to assess feasibility, acceptability and preliminary effects of telehealth-delivered cognitive-behavioral therapy ...