Opioid Tapering for Opiate Dependence

Overseen By Jeffrey Mojica, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Must be taking: Opioids

Disqualifiers: Non-English-speaking, Positive drug screen, others

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

Compensation: Varies

Number of Visits: 31

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist people who take opioids and are preparing for spine surgery by testing two methods to reduce opioid use. One group will receive education on tapering opioids, while the other group will receive the same education plus cognitive behavioral therapy (CBT) to help manage pain and emotions. Researchers seek to determine which method more effectively helps participants reduce opioid use before surgery. Candidates may be suitable if they are scheduled for spine surgery in more than four weeks, take opioids daily, and can use a computer or tablet for online sessions. As an unphased trial, this study provides a unique opportunity to explore innovative methods for reducing opioid use before surgery.

Will I have to stop taking my current medications?

The trial focuses on tapering off opioids, so you will need to reduce your opioid use before surgery. The protocol does not specify if you need to stop other medications.

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

Research has shown mixed results regarding the safety and effectiveness of reducing opioid use, with or without cognitive behavioral therapy (CBT). When combined with CBT, about 57% of new long-term, high-dose opioid users successfully reduced their use within three months. This method also lowered the risk of opioid overdose within a year after cutting back. However, opioid use disorder, a serious condition, can still lead to major health problems.

Reducing opioid use with just education can be challenging. Studies suggest this approach might increase the chances of overdose, withdrawal symptoms, and mental health issues for up to two years after reducing use. While cutting back can be helpful, it requires careful management to avoid these negative effects.

Overall, both methods offer potential benefits but also carry risks. Support systems are crucial to help manage withdrawal symptoms and provide guidance during the process. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different strategies for tapering opioids in people with opiate dependence. One approach combines opioid tapering with Cognitive Behavioral Therapy (CBT) and education, which might help people develop non-drug coping skills and manage their pain better without relying solely on medication. The other approach uses education alone, focusing on understanding the risks and process of opioid tapering. Unlike standard treatments that may not emphasize psychological support, these strategies aim to empower patients with knowledge and skills to manage withdrawal and pain, potentially improving their overall outcomes.

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

This trial will compare two approaches to opioid tapering: one with Cognitive Behavioral Therapy (CBT) and education, and another with education alone. Research has shown that combining CBT with opioid reduction can significantly aid in decreasing opioid consumption. In one study, patients who received CBT stayed off drugs for more than twice as long as those who did not. Another study found that about 40% of patients reduced their opioid use by half or more after a year when CBT was part of their treatment. While reducing opioids with education alone can be effective, it generally proves less successful than when CBT is included. Evidence suggests that education alone is somewhat helpful, but adding CBT makes a more substantial impact on lowering opioid dependence. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for patients who regularly use opioids and are scheduled for spine surgery in at least 4 weeks. It's aimed to help them reduce opioid use before surgery. People with depression, anxiety, or opioid dependence may qualify.

Inclusion Criteria

I take 40 to 120 mg of pain medication similar to morphine daily.

I am scheduled for a major spine surgery requiring at least a one-night hospital stay.

My spine surgery is scheduled at least 4 weeks from now.

Exclusion Criteria

Inability to use a computer or tablet for telemedicine encounters

Non-English-speaking

Inability to complete assessments

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Preoperative Tapering

Participants undergo opioid tapering with education alone or with education plus cognitive behavioral therapy (CBT) prior to surgery

4 weeks

Weekly assessments (in-person or virtual)

Surgery and Immediate Postoperative

Participants undergo spine surgery and immediate postoperative care, including pain and opioid use assessment

1 week

Daily monitoring (in-hospital)

Follow-up

Participants are monitored for pain, function, and opioid use at various intervals post-surgery

12 months

Assessments at 30, 90, 180, and 365 days (via telephone or Zoom)

What Are the Treatments Tested in This Trial?

Interventions

• Opioid tapering with CBT and education
• Opioid tapering with education alone

Trial Overview The study tests two methods of reducing opioid use: one group will taper off opioids with just educational support, while the other will have both education and cognitive behavioral therapy (CBT).

How Is the Trial Designed?

Group I: Opioid tapering with Cognitive Behavioral Therapy (CBT) and education Active Control 1 Intervention

The CBT group will receive two preoperative sessions and at least one postoperative session conducted via telemedicine and performed by a pain psychologist. CBT sessions will focus on training in non-pharmacologic pain-coping skills, reducing the frequency and impact of negative pain-related cognitions and emotions, and on setting realistic behavioral goals. Patients will participate in the creation of an opioid tapering plan and will receive opioid education as well as education on how to taper opioids, the possibility of increased pain, the possibility of withdrawal symptoms, and the risks related to opioids, as well as the data on worsened perioperative outcomes in patients taking opioids.

Group II: Opioid tapering with education alone Active Control 1 Intervention

In this group patients will participate in the creation of an opioid tapering plan and will receive opioid education as well as education on how to taper opioids, the possibility of increased pain, the possibility of withdrawal symptoms, and the risks related to opioids, as well as the data on worsened perioperative outcomes in patients taking opioids.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5119533/

Cognitive Behavioral Therapy Improves Treatment ... Primary prescription opioid use patients assigned to PM-CBT had more than twice the mean number of weeks of abstinence for all drugs (7.6) than ...

2. bmj.com bmj.com/content/377/bmj-2021-066375

Efficacy of interventions to reduce long term opioid ... To review interventions to reduce long term opioid treatment in people with chronic non-cancer pain, considering efficacy on dose reduction and discontinuation.

3. academic.oup.com academic.oup.com/painmedicine/article/21/8/1523/5687295

Comparative Effectiveness of Cognitive Behavioral Therapy ... At one year, 40% of patient participants with no behavioral treatment (Taper Only) will successfully reduce opioids (≥50% reduction in MEDD), ...

4. nam.edu nam.edu/perspectives/best-practices-research-gaps-and-future-priorities-to-support-tapering-patients-on-long-term-opioid-therapy-for-chronic-non-cancer-pain-in-outpatient-settings/

Best Practices, Research Gaps, and Future Priorities to ... This paper focuses on key decision points and available evidence to support tapering strategies for specific patient populations of long-term opioid use being ...

5. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/1916910

Primary Care–Based Buprenorphine Taper vs ... Results During the trial, the mean percentage of urine samples negative for opioids was lower for patients in the taper group (35.2% [95% CI, 26.2%-44.2%]) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7530567/

Comparative Effectiveness of Cognitive Behavioral Therapy ... At one year, 40% of patient participants with no behavioral treatment (Taper Only) will successfully reduce opioids (≥50% reduction in MEDD), ...

7. researchprotocols.org researchprotocols.org/2025/1/e72317

Efficacy and Safety of a Digital Tapering Intervention for ... Studies have demonstrated that a significant number of patients do not discontinue opioid treatment and continue to use opioids for months or ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2773065425000872

Association Between Opioid Dosage Tapering and ... Around 57% of new long-term high-dose opioids users tapered within 3 months. · The risk for opioid overdose reduced within 12 months after opioids tapering.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5553551/

Development of an Integrated Cognitive Behavioral ... Opioid use disorder is a highly disabling psychiatric disorder, and is associated with both significant functional disruption and risk for negative health ...