Opioid-Related Disorders Clinical Trial
Official title:
Time to Detox: A Patient-Centered Comparison of Length of Detoxification Treatment and Time to Naltrexone Maintenance Therapy in Opioid-Dependent Individuals
Verified date | October 2019 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Despite an increased focus on treating opioid use disorder there are relatively few studies that compare the length of time required for detoxification with medications other than buprenorphine. Morphine and tramadol have shorter half-lives than buprenorphine and can be used for opioid detoxification. The proposed protocol aims to address this gap by directly comparing the length of treatment required for detoxification from opioids in a patient-centered manner with oral morphine, tramadol, or buprenorphine-naloxone as well as comparing the severity of withdrawal experienced by patients in each group. The investigators predict that treatment with oral morphine or tramadol will result in a faster completion of detoxification and initiation of naltrexone maintenance.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 25, 2020 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 18-65 years of age - Meeting DSM-V criteria for opioid use disorder - Current use of opiates - Displaying evidence of opioid withdrawal - Having no significant current medical/psychiatric illness - English speaking Exclusion Criteria: - Use of methadone or buprenorphine exclusively - Pregnancy - Hypotensive - History of seizures - Physical dependence on alcohol and/or benzodiazepines that requires treatment |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to detoxification regimen completion | Will be measured from first to last dose of tapering medication | Five to twenty days | |
Primary | Time to naltrexone test dose | Measured from first dose of tapering medication to naltrexone test dose | 12 to 30 days | |
Secondary | Subjective Opiate Withdrawal Scale | The Subjective Opiate Withdrawal Scale (SOWS) measures the severity of 16 symptoms of opiate withdrawal as rated by the patient on a scale of 0 (not at all) to 4 (extremely). Total scores for each patient will be recorded each day and compared between treatment groups. | Five to twenty days | |
Secondary | Clinical Opiate Withdrawal Scale | The Clinical Opiate Withdrawal Scale (COWS) measures the severity of 11 signs and symptoms of opiate withdrawal as rated by a healthcare provider. Each symptom is rated 0 (either no symptom or abnormal sign present) to 4 or 5 (sign or symptom is prominent or severe). Scores are considered severe if greater than 36, moderately severe if 25-36, moderate if 13-25, and mild if 5-12. Maximum score possible is 48. Total scores across treatment will be compared between treatment groups. | Five to twenty days | |
Secondary | Total use of 'as needed medications' during detoxification | The following medications will be available to all patients throughout the the study; gabapentin, loperamide, ondansetron, ibuprofen, and hydroxyzine. The total amount of these 'as needed' medications will be recorded and compared between the different treatment groups. | Five to twenty days | |
Secondary | Treatment Satisfaction Survey | To assess treatment satisfaction each patient will complete a 6-question survey at the end of the study protocol. Patients will be asked to rate their satisfaction with their medication treatment, from very dissatisfied to very satisfied, how bothersome withdrawal symptoms were, from very bothersome to not at all bothersome, what if any side effects were experience, and by how much the medication reduced cravings, from not at all to completely. | One day |
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