Trials / Completed
CompletedNCT02362256
The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism
The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism With Naltrexone and Sedation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Vilnius University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to investigate which method of naltrexone induction during rapid opioid detoxification causes stronger stress response and has a higher influence on opioid abstinence caused by opioid induction.
Detailed description
Study enrolls opiate addicted patients who are motivated for a long term treatment and full opiate abstinence. Patient is offered to take part in a study. Information is provided regarding protocol, aim and course of study. Patients who are eligible and consent for study commit to follow the pre-study recommendations. Study consists of: Primary assessment - information about study. Assessment of patient according to predefined criteria. Consent form. Allocation of the treatment date. Stabilization - Buprenorphine. Assessment according to SOWS and OWS. Total amount of buprenorphine is recorded. Repeated evaluation - patient after successful stabilization course undergoes urine test for psychotropic substances, blood alcohol level is recorded. If any test is positive patient is not enrolled to study. Correction of opioid withdrawal symptoms - all of the patients receive medicines for opioid detoxification, infusion therapy in predefined doses. Antagonist induction - patients receive opioid antagonist (incremental or standard dose). Withdrawal symptoms are assessed and correction with lorazepam is given if needed. Data collection - data is recorded (demographic, epidemiological, vital signs, opioid withdrawal symptoms, levels of hormones, metabolites, electrolytes).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Naltrexone | |
| DRUG | Clonidine | |
| DRUG | Lorazepam |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2014-06-01
- Completion
- 2014-09-01
- First posted
- 2015-02-12
- Last updated
- 2015-02-12
Locations
1 site across 1 country: Lithuania
Source: ClinicalTrials.gov record NCT02362256. Inclusion in this directory is not an endorsement.