Chronic Pain, Opiate Dependence
Conditions
Brief summary
This study is designed to develop an effective psychotherapy for chronic pain and opioid dependence.
Detailed description
This study aims to develop a novel manualized intervention using tailored cognitive-behavioral treatment (CBT) and buprenorphine medication to effectively treat the co-occurring disorders of non-malignant pain and opioid dependence (POD). Specific Aims: 1. To conduct a pre-pilot phase with 16 patients with POD receiving buprenorphine maintenance treatment (BMT). In the pre-pilot phase, we will also explore the effects of different daily buprenorphine dosages on pain and opiate use. 2. To conduct a pilot randomized, clinical trial to obtain data regarding the feasibility, acceptability and efficacy (compared to Physician Management(PM) only) of manual-guided CBT or Educational Counseling (EC) for patients with POD treated with BMT (N=75). The secondary outcomes: Development of a Treatment Manual and Development and Modification of Initial Therapy Training and Process Rating Measures were process measures and not been to be included as measures associated with RCT. These outcomes were removed when the RCT results were entered. In addition, outcomes were renamed for clarification. At results entry, the timeframe (16 weeks) was also corrected to account for the actual timeframe used for analysis in the study. The 16-week study period listed in the protocol included a 2-week buprenorphine induction period (before randomization) and up to a 2-week post-conclusion of the clinical trial continuation on buprenorphine and referral to continuing treatment. In prior studies with buprenorphine, the study team had observed an artificially high attrition during the last 2 weeks of the planned study protocol, when participants were attempting to transition to available clinical treatments outside of the study. Consequently, as per the original study protocol for this study, the plan was to analyze intake and induction data (as baseline data) and then the data from the first 12-weeks post-randomization.
Interventions
BEHAVIORALCBT
Cognitive behavioral therapy
DRUGBuprenorphine
buprenorphine/naloxone
Didactic, lecture-discussion format to supplement information and advice provided by physicians
OTHERPhysician Management
Brief physician counseling
Sponsors
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * prescription opioid addiction criteria * moderate to severe chronic pain * seeking or interested in buprenorphine maintenance * understand English
Exclusion criteria
* methadone maintenance at a dose greater than 40 mg daily * current suicide or homicide risk * life-threatening or unstable medical problem * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 3 months | Pain intensity comprises the average of 4 items related to current pain and past-week average pain, pain at its worst, and pain at its least. Pain intensity is scored on 0-10 scale (average score ranges from 0-10), where higher scores indicate higher pain intensity.Originally labeled as Pain Reduction at 16 weeks- 3 months was the correct timeframe. |
| Number of Opioid-negative Urine Toxicology Tests | 3 Months | Reduced illicit opioid use is defined as the number of documented opioid negative urine tests in each of the time periods.This measures the reduction in illicit opioid use - more opioid-negative tests means greater reductions in illicit opioid use. The highest possible score is 4- which would indicate 4 negative urine tests during the assessment period. Originally titled Reduced illicit opioid use and the timeframe was listed as 16 weeks. |
| Pain Interference | 3 Months | Pain interference comprises the average of 7 items related to past-week pain-related interference in general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. Each item is scored on a 0-10 scale (averaged 0-10), where higher scores indicate higher pain interference. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CBT for POD Integrated cognitive behavioral therapy for chronic pain and opioid dependence
CBT: Cognitive behavioral therapy
Buprenorphine: buprenorphine/naloxone | 30 |
| Educational Counseling for POD Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)
Buprenorphine: buprenorphine/naloxone
Educational Counseling: Didactic, lecture-discussion format to supplement information and advice provided by physicians | 30 |
| Physician Management PM is a relatively brief intervention that approximates the medically focused advice and brief counseling about medical issues that is typically provided by physicians to patients with chronic pain or other chronic medical conditions, such as diabetes or asthma.
Buprenorphine: buprenorphine/naloxone
Physician Management: Brief physician counseling | 30 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 7 | 7 |
Baseline characteristics
| Characteristic | Educational Counseling for POD | Physician Management | CBT for POD | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 30 Participants | 90 Participants |
| Age, Continuous | 37.0 years STANDARD_DEVIATION 9.9 | 35.3 years STANDARD_DEVIATION 10 | 35.3 years STANDARD_DEVIATION 9.4 | 35.8 years STANDARD_DEVIATION 9.8 |
| Region of Enrollment United States | 30 participants | 30 participants | 30 participants | 90 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 19 Participants | 39 Participants |
| Sex: Female, Male Male | 20 Participants | 20 Participants | 11 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Number of Opioid-negative Urine Toxicology Tests
Reduced illicit opioid use is defined as the number of documented opioid negative urine tests in each of the time periods.This measures the reduction in illicit opioid use - more opioid-negative tests means greater reductions in illicit opioid use. The highest possible score is 4- which would indicate 4 negative urine tests during the assessment period. Originally titled Reduced illicit opioid use and the timeframe was listed as 16 weeks.
Time frame: 3 Months
Population: The analysis population is the intention to treat population and all observations across time periods were used in the analysis. Participants may have contributed to this outcome but were lost to follow up during the time period and were not measured on pain related outcomes.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT for POD | Number of Opioid-negative Urine Toxicology Tests | Intake/Induction | 0.67 opioid negative urine tests | Standard Deviation 0.55 |
| CBT for POD | Number of Opioid-negative Urine Toxicology Tests | Month 1 | 2.67 opioid negative urine tests | Standard Deviation 1.42 |
| CBT for POD | Number of Opioid-negative Urine Toxicology Tests | Month 2 | 2.96 opioid negative urine tests | Standard Deviation 1.48 |
| CBT for POD | Number of Opioid-negative Urine Toxicology Tests | Month 3 | 2.80 opioid negative urine tests | Standard Deviation 1.38 |
| Educational Counseling for POD | Number of Opioid-negative Urine Toxicology Tests | Month 3 | 3.25 opioid negative urine tests | Standard Deviation 1.22 |
| Educational Counseling for POD | Number of Opioid-negative Urine Toxicology Tests | Intake/Induction | 0.67 opioid negative urine tests | Standard Deviation 0.48 |
| Educational Counseling for POD | Number of Opioid-negative Urine Toxicology Tests | Month 2 | 3.30 opioid negative urine tests | Standard Deviation 1.14 |
| Educational Counseling for POD | Number of Opioid-negative Urine Toxicology Tests | Month 1 | 2.80 opioid negative urine tests | Standard Deviation 1.27 |
| Physician Management | Number of Opioid-negative Urine Toxicology Tests | Month 3 | 2.04 opioid negative urine tests | Standard Deviation 1.71 |
| Physician Management | Number of Opioid-negative Urine Toxicology Tests | Month 1 | 2.48 opioid negative urine tests | Standard Deviation 1.7 |
| Physician Management | Number of Opioid-negative Urine Toxicology Tests | Month 2 | 2.56 opioid negative urine tests | Standard Deviation 1.72 |
| Physician Management | Number of Opioid-negative Urine Toxicology Tests | Intake/Induction | 0.55 opioid negative urine tests | Standard Deviation 0.69 |
Primary
Pain Intensity
Pain intensity comprises the average of 4 items related to current pain and past-week average pain, pain at its worst, and pain at its least. Pain intensity is scored on 0-10 scale (average score ranges from 0-10), where higher scores indicate higher pain intensity.Originally labeled as Pain Reduction at 16 weeks- 3 months was the correct timeframe.
Time frame: 3 months
Population: The analysis population is the intention to treat population and all observations across time periods were used in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT for POD | Pain Intensity | Month 3 | 4.41 units on a scale | Standard Deviation 1.67 |
| CBT for POD | Pain Intensity | Intake/Induction | 5.43 units on a scale | Standard Deviation 1.34 |
| CBT for POD | Pain Intensity | Month 1 | 4.75 units on a scale | Standard Deviation 1.62 |
| CBT for POD | Pain Intensity | Month 2 | 4.79 units on a scale | Standard Deviation 1.5 |
| Educational Counseling for POD | Pain Intensity | Month 2 | 4.98 units on a scale | Standard Deviation 1.76 |
| Educational Counseling for POD | Pain Intensity | Month 3 | 4.62 units on a scale | Standard Deviation 1.91 |
| Educational Counseling for POD | Pain Intensity | Month 1 | 5.02 units on a scale | Standard Deviation 1.45 |
| Educational Counseling for POD | Pain Intensity | Intake/Induction | 5.92 units on a scale | Standard Deviation 1.57 |
| Physician Management | Pain Intensity | Month 2 | 4.72 units on a scale | Standard Deviation 1.81 |
| Physician Management | Pain Intensity | Intake/Induction | 5.28 units on a scale | Standard Deviation 1.34 |
| Physician Management | Pain Intensity | Month 1 | 4.53 units on a scale | Standard Deviation 1.46 |
| Physician Management | Pain Intensity | Month 3 | 4.84 units on a scale | Standard Deviation 1.91 |
Primary
Pain Interference
Pain interference comprises the average of 7 items related to past-week pain-related interference in general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. Each item is scored on a 0-10 scale (averaged 0-10), where higher scores indicate higher pain interference.
Time frame: 3 Months
Population: The analysis population is the intention to treat population and all observations across time periods were used in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT for POD | Pain Interference | Intake/Induction | 5.75 units on a scale | Standard Deviation 2.12 |
| CBT for POD | Pain Interference | Month 1 | 4.15 units on a scale | Standard Deviation 2.09 |
| CBT for POD | Pain Interference | Month 2 | 4.08 units on a scale | Standard Deviation 2.06 |
| CBT for POD | Pain Interference | Month 3 | 3.22 units on a scale | Standard Deviation 1.94 |
| Educational Counseling for POD | Pain Interference | Month 3 | 3.23 units on a scale | Standard Deviation 2.27 |
| Educational Counseling for POD | Pain Interference | Intake/Induction | 5.48 units on a scale | Standard Deviation 2.23 |
| Educational Counseling for POD | Pain Interference | Month 2 | 3.61 units on a scale | Standard Deviation 1.97 |
| Educational Counseling for POD | Pain Interference | Month 1 | 3.74 units on a scale | Standard Deviation 1.82 |
| Physician Management | Pain Interference | Month 3 | 3.87 units on a scale | Standard Deviation 2.56 |
| Physician Management | Pain Interference | Month 1 | 3.32 units on a scale | Standard Deviation 2.12 |
| Physician Management | Pain Interference | Month 2 | 3.45 units on a scale | Standard Deviation 2.45 |
| Physician Management | Pain Interference | Intake/Induction | 5.01 units on a scale | Standard Deviation 2.19 |