Opioid Dependence
Conditions
Keywords
Opioid Dependence, Buprenorphine
Brief summary
Buprenorphine/naloxone (BUP/NLX) treatment is effective for the treatment of prescription opioid dependence, previous studies have not determined the optimum dose of BUP/NLX for this patient population. The goal of this study is to determine if there are differences in clinical efficacy of BUP/NLX tablet in low dose range (less than or equal to 8/2mg) vs. high dose range (greater than or equal to 16, range 16-24mg). The main outcomes of interest will be treatment retention, use of opioids, and the use of other drugs of abuse.
Detailed description
This is a randomized, open-label clinical trial with approximately 9 Veteran opioid dependent men and women. Veterans were randomized to one of two treatment groups: low dose range of buprenorphine (\<8mg) vs. high dose range of buprenorphine/naloxone (BUP/NLX (\<16mg). During induction into buprenorphine, all participants will be started at a dose of 2mg, and this dose will be increased as needed for stabilization of opioid withdrawal symptoms, up to 8mg for the low dose group, and up to 16mg for the high dose group, within a 5 day period. Participants will be seen on a daily basis (excluding weekends) for the initial 5 day induction. At the end of the 12-week study, participants will either be referred to a buprenorphine clinic if they wish to continue this medication, or if they wish to be drug free, will undergo detoxification from buprenorphine for up to a 4-week period. Follow-up visits, scheduled at 1, 3, and 6 months after study completion.
Interventions
DRUGBuprenorphine
Sponsors
United States Department of Defense
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
1. Males and females between the ages of 18 to 65, current dependence on prescription opioids as evidenced by documented prior treatment for opioid dependence, signs of opiate withdrawal as evidenced by a Clinical Opiate Withdrawal Scale score of 7 or greater, self-reported history of opioid dependence, and a positive urine toxicology for opiates; 2. willingness to be detoxified from opioids for buprenorphine maintenance ; 3. for women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy, with monthly pregnancy tests obtained during study participation.
Exclusion criteria
1. use of heroin for more than 4 days in the past month; 2. lifetime history of opioid dependence due to heroin alone; 3. ever used heroin intravenously; 4. requirement for current ongoing opioid treatment for adequate pain management; 5. current alcohol, benzodiazepine, barbiturate use with physiologic dependence as determined during screening history and physical, 6. serious unstable medical illness including bradycardia or other arrhythmias, major cardiovascular, renal, endocrine, or hepatic disorders for which buprenorphine treatment is contraindicated or which at the determination of the MD is medically dangerous; 7. serious psychiatric illness including psychosis, bipolar disorder with psychosis: 8. or significant current suicidal or homicidal thoughts necessitating a higher level or care; 9. known allergy or intolerance to buprenorphine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine Toxicology for Opiate Use | Weeks 1-12 | Will be used to document opioid use, a urine toxicology screening will be completed weekly during study participation (12 week study) |
| Urine Toxicology | Weeks 1-12 | Will be used to document cannabinoid use, a urine toxicology screening will be completed weekly during study participation (12 week study) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Buprenorphine Low Dose Participants in this arm will receive a low dose (less than or equal to 8/2mg) of buprenorphine for 12 weeks.
Buprenorphine | 5 |
| Buprenorphine High Dose Participants in this arm will receive a high dose (16-24mg) of buprenorphine for 12 weeks.
Buprenorphine | 4 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | did not show up for appointment and did not return calls after week 11 | 0 | 1 |
| Overall Study | did not show up for appointment and did not return calls after week 9 | 1 | 0 |
Baseline characteristics
| Characteristic | Buprenorphine High Dose | Total | Buprenorphine Low Dose |
|---|---|---|---|
| Age, Continuous | 43.25 years STANDARD_DEVIATION 16.72 | 40.67 years STANDARD_DEVIATION 14.01 | 38.60 years STANDARD_DEVIATION 13.07 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 0 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 |
Outcome results
Primary
Urine Toxicology
Will be used to document cannabinoid use, a urine toxicology screening will be completed weekly during study participation (12 week study)
Time frame: Weeks 1-12
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Buprenorphine Low Dose | Urine Toxicology | Negative urine toxicology for cannabinoids | 3 Participants |
| Buprenorphine Low Dose | Urine Toxicology | Less than 6 positive urine toxicology for cannabinoids during 12 week study | 1 Participants |
| Buprenorphine Low Dose | Urine Toxicology | More than 6 positive urine toxicology for cannabinoids during 12 week study | 1 Participants |
| Buprenorphine High Dose | Urine Toxicology | Negative urine toxicology for cannabinoids | 3 Participants |
| Buprenorphine High Dose | Urine Toxicology | Less than 6 positive urine toxicology for cannabinoids during 12 week study | 0 Participants |
| Buprenorphine High Dose | Urine Toxicology | More than 6 positive urine toxicology for cannabinoids during 12 week study | 1 Participants |
Primary
Urine Toxicology for Opiate Use
Will be used to document opioid use, a urine toxicology screening will be completed weekly during study participation (12 week study)
Time frame: Weeks 1-12
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Buprenorphine Low Dose | Urine Toxicology for Opiate Use | Negative urine toxicology for opiates | 2 Participants |
| Buprenorphine Low Dose | Urine Toxicology for Opiate Use | One positive urine toxicology for opiates during 12 week study | 2 Participants |
| Buprenorphine Low Dose | Urine Toxicology for Opiate Use | Two positive urine toxicology for opiates during 12 week study | 1 Participants |
| Buprenorphine High Dose | Urine Toxicology for Opiate Use | Negative urine toxicology for opiates | 4 Participants |
| Buprenorphine High Dose | Urine Toxicology for Opiate Use | One positive urine toxicology for opiates during 12 week study | 0 Participants |
| Buprenorphine High Dose | Urine Toxicology for Opiate Use | Two positive urine toxicology for opiates during 12 week study | 0 Participants |