A Depression and Opioid Pragmatic Trial in Pharmacogenetics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,284
- 试验地点
- 24
- 主要终点
- Number of Individuals Identified as Potential Participants Through EHR (Electronic Health Record)
研究概览
简要总结
This is a Master Protocol Screening record. This study is comprised of three separate pharmacogenetic trials grouped into a single protocol due to similarities in the intervention, the hypotheses, and the trial design. The three trials are the Acute Pain Trial, the Chronic Pain Trial, and the Depression Trial. Participants can enroll in only one of the three trials.
Each trial is listed individually on clinicaltrials.gov and includes "PRO00104948" within the Unique Protocol ID:
PRO00104948_A - Acute Pain Trial - NCT05966129
PRO00104948_B - Chronic Pain Trial - NCT05966142
PRO00104948_C - Depression Trial - NCT05966155
Acute Pain Trial: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided post-surgical opioid therapy (Intervention arm) or standard care and pharmacogenetic testing after 6 months (Control arm). The investigators will test the hypothesis that pharmacogenetic testing and genotype guided pain management therapy improves pain control after surgery in participants who's body processes some pain medicines slower than normal.
Chronic Pain Trial: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided opioid therapy (Intervention arm) or standard care with 6-month delayed pharmacogenetic testing (Control arm). The investigators will test the hypothesis that pharmacogenetic testing and genotype guided pain therapy improves pain control after surgery in participants who's body processes some pain medicines slower than normal.
Depression: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided anti-depressant therapy (Intervention arm) or standard care with 6-month delayed pharmacogenetic testing (Control arm). The investigators will test the hypothesis that pharmacogenetic testing and genotype-guided anti-depressant therapy will reduce depression symptoms in participants who's body processes some anti-depressants faster or slower than normal.
详细描述
Pain and depression are conditions that impact substantial proportions of the US population. Finding safe and effective drug therapies for both conditions is challenging. In the case of treatment for acute and chronic pain, the challenge is finding effective therapy while minimizing adverse effects or opioid addiction (and the ensuing consequences). For depression, there are few clinically relevant predictors of successful treatment leading to multiple trials of inadequate therapy for some patients. Both opioid and antidepressant prescriptions can be guided by pharmacogenetics (PGx) data based on existing guidelines from the Clinical Pharmacogenetics Implementation Consortium (CPIC).
This study is designed to evaluate the impact of pharmacogenetic testing and genotype-guided pain or anti-depressant therapy on pain control or depression symptoms in a pragmatic setting.
The rationale for examining a genotype-guided approach to acute and chronic pain management is based on the importance of CYP2D6 for the bioactivation of tramadol, codeine, and hydrocodone and data from a pilot study supporting improved pain control in intermediate and poor CYP2D6 metabolizers in the genotype-guided arm who are taking these drugs at baseline. Similarly, the rationale for examining a genotype-guided approach to depression medication therapy is based on the demonstrated role of CYP2D6 in the bio inactivation and CYP2C19 oxidation of select, commonly used SSRIs. Secondly, data from industry sponsored trials support the hypothesis of improved depression symptom control in a genotype-guided arm.
Study objectives:
Acute Pain Trial: Determine if a genotype-guided approach to acute post-surgical pain therapy leads to improved pain control compared to usual care, as defined by a decrease in the SIA score. Secondarily, The investigators will evaluate whether this approach leads to reduced use of DEA Schedule II opioids and reduced pain intensity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 8 years
- •English speaking or Spanish speaking
- •Elective/planned surgery types with planned or anticipated to be treated with tramadol, hydrocodone, or codeine pain management at an enrolling site, which may include orthopedic surgeries (e.g. arthroplasty, spine, etc.), open abdominal surgery, or cardiothoracic surgery and others
- •Chronic Pain
- •Age ≥ 18 years
- •English speaking or Spanish speaking
- •Seen at primary care clinics (such as, but not limited to, Internal Medicine, Family Medicine or Pediatrics) or patients seen in pain-relevant specialty clinics
- •History of pain for at least the last 3 months
- •Currently treated or being considered for treatment with tramadol, hydrocodone, or codeine to improve pain management
- •Age ≥ 8 years
- •English speaking or Spanish speaking
- •Patients followed at psychiatry clinics or primary care clinics at an enrolling site (such as, but not limited to, Internal Medicine, Family Medicine, or Pediatrics)
- •Documentation of depression and/or provider report of depression
- •Evidence of depressive symptoms for at least 3 months based on patient interview or documentation in electronic health records
- •Recent initiation of SSRI therapy, recent revised SSRI therapy, or anticipated need for revised or new SSRI therapy per health care provider
- •Exclusion Criteria
- •Trial-wide:
- •Life expectancy less than 12 months
- •Are too cognitively impaired to provide informed consent and/or complete study protocol
- •Are institutionalized or too ill to participate (i.e. mental or nursing home facility or incarcerated)
- •Have a history of allogeneic stem cell transplant or liver transplant
- •People with prior clinical pharmacogenetic test results for genes relevant for the study in which they will enroll (CYP2D6 for the pain studies and CYP2D6 or CYP2C19 for depression) or already enrolled in an ADOPT PGx trial
- •Undergoing a laparoscopic surgery
- •Receiving chronic opioid therapy, defined as use of opioids on most days for >3 months
- •Chronic Pain
- •Plan to move out of the area within 6 months of enrollment
- •Undergoing treatment for an active cancer diagnosis
- •Currently taking daily opioids other than tramadol, codeine or hydrocodone
- •Plan to move out of the area within 6 months of enrollment
- •Have active psychosis or diagnosed psychotic disorders (schizophrenia, schizoaffective disorder, delusional disorder, psychotic depression, substance induced psychosis, schizophreniform disorder)
- •Have dementia or other neurocognitive disorders due to any cause, such as Alzheimer's disease, vascular/subcortical, lewy body disease, frontotemporal lobar degeneration
- •Have cognitive developmental delay and/or cognitive disability, including autism spectrum disorders (Note: ADHD is not an exclusion criteria)
- •Has a seizure disorder
- •Have bipolar disorder
排除标准
- 未提供
结局指标
主要结局
Number of Individuals Identified as Potential Participants Through EHR (Electronic Health Record)
时间窗: Up to 3 years
Potential participants identified for the Acute Pain, Chronic Pain, and Depression Trials through EHR.
Number of Individuals Who Were Screened to the Acute Pain, Chronic Pain, and Depression Trials
时间窗: Up to 3 years
Individuals who were screened to be in the Acute Pain, Chronic Pain and Depression Trials.
Number of Participants Who Were Randomized to the Acute Pain, Chronic Pain, and Depression Trials
时间窗: Up to 3 years
Individuals who were randomized to be in the Acute Pain, Chronic Pain and Depression Trials.
次要结局
- Pain Interference as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)(6 months)
- Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)(6 months)
- Sleep Disturbance as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)(6 months)
- Ability to Participant in Social Roles and Activities as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)(6 months)
- Fatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)(6 months)
- Depression as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)(6 months)
- Anxiety as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)(6 months)
- Overall Wellbeing as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)(6 months)
- Number of Participants With Pharmacogenetic Drug-Gene Concordance(10 days for Acute Pain; 3 months for Chronic Pain and Depression)