Opiate Addiction, Refractory Pain
Conditions
Keywords
drug dependence, substance abuse, substance use disorders, myofascial pain syndrome, neuralgia, back pain
Brief summary
This study is designed to determine if different doses of buprenorphine (either tapering doses or steady doses) are effective in managing chronic, non-cancer pain in individuals who also are addicted to opiate pain medicines.
Detailed description
Context: Some individuals have two conditions: 1) a well-documented pain disorder and 2) clear evidence of a substance use disorder with opiate dependency. It is not known how to manage these patients. In addition to other modalities for the treatment of chronic pain, combination tablets of buprenorphine/naloxone (Suboxone) may be helpful. Objective: The objective of this study is to determine if the addition of pharmacotherapy with Suboxone to usual care would improve clinical outcome relative to usual care alone. Design: Randomized control trial. Setting: The study will be conducted in the out-patient clinics of a tertiary-care teaching hospital. Participants: The participants will be those who have: 1) a well-documented pain disorder and 2) clear evidence of a substance use disorder with opiate dependency. Baseline data collected: Data collected at baseline will include (with examples): demographics (age, gender, race), substance use history (type of substances used, duration of use, routes of abuse), type of pain disorder (previous traumatic injury, musculoskeletal, neuropathic), co-existing medical problems (seizures, hepatitis C), prior injuries (accidents, interpersonal violence), prior mental health problems (prior treatment, diagnoses), prior substance abuse treatment (outpatient, inpatient), socioeconomic variables (educational level, occupation, employment history), criminal history (number of arrests and convictions, total amount of time spent in jail or prison), family history (first degree relatives with substance use disorders) and scores on psychometric testing (ASI). Outcome data: Three main outcome variables will be examined relapse to substance use (as documented by toxicology), quality of life, and successful participation in the pain management program for six months, which included the completion of the study buprenorphine treatment protocols. Data analyses: Outcome variables will be compared between the two groups using t-tests or chi-square tests as appropriate. A Kaplan-Myer survival analysis will be used to describe participant participation. Predictors of poor outcomes will be identified using a case-control design in which those with poor outcomes (the cases) will be compared to those with successful outcomes (the controls) using multivariate techniques (logistic regression).
Interventions
DRUGbuprenorphine/naloxone
sublingual tablets, 2/0.5 mg, three times a day for one month, twice a day for one month, once a day for one month, then every other day for one month. (dose may be adjusted based on an individual's response)
Sponsors
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of chronic refractory pain * Clinical diagnosis of opiate dependency
Exclusion criteria
* unable to pay for medication * enrolled in a methadone maintenance program * homelessness * major mental illness * pregnant women * prisoners * terminal cancer pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse to Substance Abuse | Six months | Relapse to substance abuse (yes/no) was determined by participant self-report or by a positive urine toxicology. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Better Overall Quality of Life at Six Months as Compared to Baseline. | Baseline and six months | Qualitative measure (better/no change/worse) of participant's perception of overall quality of life related to assigned study protocol arm. |
| Treatment Retention. | Six months | Treatment retention was defined as the completion of the buprenorphine dosing protocol (i.e., tapering doses vs. steady doses). |
Countries
United States
Participant flow
Recruitment details
12 participants recruited Dec 2007 to Apr 2008
Participants by arm
| Arm | Count |
|---|---|
| Tapering Doses of Buprenorphine Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification. | 6 |
| Steady Dose of Buprenorphine Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance. | 6 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Steady Dose of Buprenorphine | Tapering Doses of Buprenorphine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 6 Participants | 12 Participants |
| Age Continuous | 46 years STANDARD_DEVIATION 15 | 44 years STANDARD_DEVIATION 6 | 45 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 6 participants | 6 participants | 12 participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Relapse to Substance Abuse
Relapse to substance abuse (yes/no) was determined by participant self-report or by a positive urine toxicology.
Time frame: Six months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tapering Doses of Buprenorphine | Relapse to Substance Abuse | 2 participants |
| Steady Dose of Buprenorphine | Relapse to Substance Abuse | 4 participants |
Comparison: Intent to treatp-value: 0.52395% CI: [0.0098, 2.8215]Fisher Exact
Secondary
Number of Participants With Better Overall Quality of Life at Six Months as Compared to Baseline.
Qualitative measure (better/no change/worse) of participant's perception of overall quality of life related to assigned study protocol arm.
Time frame: Baseline and six months
Population: Reported value (number) was the number who reported a better overall quality-of-life to the question: How would you describe your overall level of function now as compared to the time right before you started the study? Responses were recorded as: better, no change, or worse.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tapering Doses of Buprenorphine | Number of Participants With Better Overall Quality of Life at Six Months as Compared to Baseline. | 4 Participants |
| Steady Dose of Buprenorphine | Number of Participants With Better Overall Quality of Life at Six Months as Compared to Baseline. | 4 Participants |
Secondary
Treatment Retention.
Treatment retention was defined as the completion of the buprenorphine dosing protocol (i.e., tapering doses vs. steady doses).
Time frame: Six months
Population: Analysis was intent-to-treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tapering Doses of Buprenorphine | Treatment Retention. | 0 Participants |
| Steady Dose of Buprenorphine | Treatment Retention. | 5 Participants |
Comparison: Fisher exact test was used and tested the hypothesis that neither group would be more likely to complete the study protocol.p-value: 0.015Fisher Exact