DOTS Intervention for Opioid Withdrawal
(DOTS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to help individuals taper off opioids after orthopedic surgery. It provides a personalized plan for reducing opioid use, including a tailored schedule, a handout, and phone support after hospital discharge. Researchers aim to determine if this approach, known as the DOTS Intervention, reduces unnecessary opioid prescriptions and enhances recovery. Suitable participants have recently undergone orthopedic surgery, did not use opioids before the operation, and can manage their medications. This trial specifically seeks to improve outcomes by reducing opioid reliance and enhancing recovery. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance post-surgery recovery for many patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require that you have not used opioids in the past month before surgery.
What prior data suggests that the DOTS intervention is safe for patients?
Research has shown that the DOTS intervention helps manage opioid withdrawal by providing a plan to gradually reduce opioid use. This approach aims to lower the risk of severe withdrawal symptoms that can occur if opioids are stopped suddenly.
Although specific safety data for the DOTS intervention is not available, it involves a gradual reduction in opioid use, which is generally safer than abrupt cessation. The intervention includes support materials for patients, such as a handout and phone support after discharge, to help manage potential withdrawal issues.
The DOTS intervention tests a new method for managing opioid prescriptions and supporting patients, not a new drug. This likely reduces the risk of negative side effects compared to trials involving new medications. However, as with any treatment change, monitoring patients for unexpected effects is important.
In summary, while detailed safety data for DOTS is lacking, the gradual approach and supportive elements suggest it may be well-tolerated.12345Why are researchers excited about this trial?
Researchers are excited about the DOTS Intervention for opioid withdrawal because it aims to enhance treatment outcomes by introducing structured, stepwise care. Unlike traditional treatment approaches, which often involve medication-assisted therapy and supportive counseling, the DOTS Intervention focuses on a progressive method of care delivery. This approach integrates Treatment as Usual (TAU) and adds new steps in a phased manner, potentially offering more tailored support for individuals during their withdrawal process. By evaluating different timing strategies for introducing these steps, researchers hope to discover the most effective way to reduce withdrawal symptoms and improve recovery success.
What evidence suggests that the DOTS intervention is effective for reducing opioid prescribing after orthopedic surgery?
Research has shown that treatments other than opioids can ease withdrawal symptoms during opioid reduction. This trial evaluates the DOTS method for its effectiveness in managing opioid prescriptions post-surgery by creating a personalized plan to gradually reduce their use. This approach can lead to fewer prescribed opioid pills and improved pain relief for patients. Studies suggest that these specific tapering strategies can reduce the need for long-term opioid use. Additionally, older and more fragile patients might benefit even more from DOTS, experiencing fewer side effects and better recovery. Participants in this trial will join either the Early-Step DOTS Intervention or the Late-Step DOTS Intervention to assess the timing and effectiveness of the DOTS method.678910
Who Is on the Research Team?
Justina Groeger, MD
Principal Investigator
Montefiore Medical Center
Are You a Good Fit for This Trial?
This trial is for adults (18 or older) who have had orthopedic surgery during a hospital stay and did not use opioids in the month before surgery. People with recent opioid use are not eligible.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a discharge opioid taper support (DOTS) intervention tailored to their analgesic needs after orthopedic surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pain intensity and opioid use
Long-term Follow-up
Participants are monitored for long-term opioid use and outcomes
What Are the Treatments Tested in This Trial?
Interventions
- DOTS Intervention
Trial Overview
The study compares usual care, telephonic support, and a new DOTS intervention that helps doctors prescribe tailored opioid tapering plans after surgery. Patients are randomly assigned based on their provider's group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
The study will be divided into three equal time periods. Providers in this arm will conduct TAU in the first period, be assigned to TS in the second period, and be assigned to DOTS in the third period.
The study will be divided into three equal time periods. Providers in this arm will conduct TAU in the first period, and be assigned to DOTS in the second and third period.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Montefiore Medical Center
Lead Sponsor
Citations
Effectiveness of non-opioid interventions to reduce ... - PMC
We conducted a systematic review of controlled studies on interventions aimed at reducing withdrawal symptoms during opioid tapering in patients with long term ...
DOTS Intervention for Opioid Withdrawal (DOTS Trial)
Hypothesis 4: Age and frailty will be moderators; DOTS will be more effective at improving positive and reducing negative outcomes in older and ...
Comparative Effectiveness of Different Treatment Pathways ...
Treatment with buprenorphine or methadone was associated with reductions in overdose and serious opioid-related acute care use compared with other treatments.
Differences in patient-reported and observer-rated opioid ...
Data suggest the patient-reported SOWS demonstrated a higher level of symptom endorsement, earlier detection of symptom onset, and better association with ...
Programs for the Reduction or Discontinuation of Opioids or ...
The aim of this report is to review the clinical effectiveness and safety of different opioid addiction programs for the management and ...
Opioid Withdrawal - StatPearls - NCBI Bookshelf - NIH
Opioid withdrawal syndrome is a life-threatening condition resulting from opioid dependence. Opioids are a group of drugs used to manage severe pain.
Study Details | NCT07466784 | CEDRN: Opioid Registry
Outcomes will include: (a) emergency department discharge, (b) leaving against medical advice or without being seen, (c) hospitalization, (d) naloxone ...
Improving hospital care for people who use drugs: deliberative ...
Here, we detail the process and outcomes of revising the opioid withdrawal management guideline at University College London Hospital (UCLH) ...
Rapid Initiation of Injection Naltrexone for Opioid Use ...
Secondary outcomes included opioid withdrawal scores and targeted safety events and serious adverse events. All analyses were intention-to-treat ...
Is Buprenorphine Safer Than Other Treatments?
Buprenorphine is effective in managing opioid withdrawal without adverse effects, but unless buprenorphine is followed up with longer-term maintenance ...
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