Opiate AddictionNCT02362256
The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism
A study testing Naltrexone, Clonidine and Lorazepam in people with Opiate Addiction, run by Vilnius University at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opiate Addiction
- What is being tested?
- Naltrexone, Clonidine and Lorazepam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteLithuania
- Study dates
- May 2014to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Opiate addiction
- Use of short-acting opiate (morphine or heroine)
- Age > 18 years
- Length of opiate addiction > 1 year
- Patient can make a decision for detoxification and has a capacity to consent for procedure
- Written consent for procedure
Who cannot join
- Polyvalent addiction
- Pregnancy or breast feeding
- Cardiovascular pathology
- Acute or chronic kidney disease
- Decompensated liver pathology (jaundice, ascites, hepatic encephalopathy)
- Infective complications of opiate addiction (pneumonia, phlegmon, abscess, thombophlebitis, sepsis)
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- Malnutrition (Nutritional risk screening 2002 score ≥3)
- Diabetes mellitus
- Previous history of psychosis
- Glasgow coma scale < 15
- Abdominal surgical intervention during last 30 days
- Cumulative buprenorphine dose for stabilization < 8 mg
- Positive test for psychoactive substances during treatment
- Refusal to participate in study at any point of it
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Republic Vilnius University Hospital
Vilnius, Vilnius County, LT-04130
About this study
Official title: The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism With Naltrexone and Sedation
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.
Read the 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
- Opiate Addiction
- Being tested
- Naltrexone, Clonidine, Lorazepam
- Keywords
- Opioid detoxification, Opioid antagonist induction, Conscious sedation
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Also called Vivitrol, Revia
ClonidineDrug
Also called Catapres, Kapvay
LorazepamDrug
Also called Ativan
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Opioid antagonist induction. Day 4. Duration 12-16 hours.
Naltrexone gradual increase from 50 µg p/o to a total dose of 12,5 mg according to a predefined protocol:
1. st hour 50 µg
2. nd hour 50 µg
3. rd hour 100 µg
4. th hour 100 µg
5. th hour 200 µg
6. th hour 400 µg
7. th hour 800 µg
8. th hour 1600 µg
9. th hour 3200 µg
10. th hour 6000 µg
Correction of symptoms for opioid abstinence:
Clonidine 150 µg p/o every 4 hours (Day 3 and Day 4) Lorazepam 5 mg p/o every 4 hours (Day 3 and Day 4), Lorazepam 2,5 mg po every 4 hours (Day 5, Day 6) Receives: Drug: Naltrexone; Drug: Clonidine; Drug: Lorazepam |
| Control | Active comparator | Opioid antagonist induction. Day 4. Duration 12-16 hours. Naltrexone single dose 12,5 mg p/o
Correction of symptoms for opioid abstinence:
Clonidine 150 µg p/o every 4 hours (Day 3 and Day 4) Lorazepam 5 mg p/o every 4 hours (Day 3 and Day 4), Lorazepam 2,5 mg po every 4 hours (Day 5, Day 6) Receives: Drug: Naltrexone; Drug: Clonidine; Drug: Lorazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol levels
Cortisol levels were assessed 4 times starting on intervention day (1 hour before intervention, 1, 5 and 23 hours post-intervention)
Measured: 2 days
Adrenocorticotropic hormone (ACTH) levels
Cortisol levels were assessed 4 times starting on intervention day (1 hour before intervention, 1, 5 and 23 hours post-intervention)
Measured: 2 days
Secondary outcomes (10)
Stress response levels according to heart rate
Heart rate measurements were taken 4 times a day
Measured: 4 days
Stress response levels according to respiratory rate
Respiratory rate measurements were taken 4 times a day
Measured: 4 days
Stress response levels according to blood pressure
Blood pressure measurements were taken 4 times a day
Measured: 4 days
Changes of potassium concentration due to stress response
Blood samples were taken 3 times a day
Measured: 4 days
Changes of sodium concentration due to stress response
Blood samples were taken 3 times a day
Measured: 4 days
Changes of chloride concentration due to stress response
Blood samples were taken 3 times a day
Measured: 4 days
Changes of magnesium concentration due to stress response
Blood samples were taken 3 times a day
Measured: 4 days
Changes of glucose concentration due to stress response
Blood samples were taken 3 times a day
Measured: 4 days
Subjective Opiate Withdrawal Scale (SOWS)
Patients were assessed with to SOWS 4 times a day
Measured: 4 days
Objective Opiate Withdrawal Scale (OOWS)
Patients were assessed with to OOWS 4 times a day
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startMay 2014
- Primary completionJun 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robertas Badaras, Vilnius University
- Investigators
- ROBERTAS BADARAS, MD, Principal investigator, Vilnius University Clinic of Anaesthesiology and Intensive CareJUOZAS IVASKEVICIUS, PROFESSOR, Study director, Vilnius University Clinic of Anaesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362256
- Sponsor's protocol ID
- 158200-01-443-124
- Status last verified
- Feb 2015
- First submitted
- 18 Jan 2015
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism With Naltrexone and Sedation
- ClinicalTrials.gov ID
- NCT02362256
- Acronym / sponsor ID
- 158200-01-443-124
- Conditions
- Opiate Addiction
- Keywords
- Opioid detoxification, Opioid antagonist induction, Conscious sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 12 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Naltrexone, Drug: Clonidine, Drug: LorazepamOpioid antagonist induction. Day 4. Duration 12-16 hours. Naltrexone gradual increase from 50 µg p/o to a total dose of 12,5 mg according to a predefined protocol: 1. st hour 50 µg 2. nd hour 50 µg 3. rd hour 100 µg 4. th hour 100 µg 5. th hour 200 µg 6. th hour 400 µg 7. th hour 800 µg 8. th hour 1600 µg 9. th hour 3200 µg 10. th hour 6000 µg Correction of symptoms for opioid abstinence: Clonidine 150 µg p/o every 4 hours (Day 3 and Day 4) Lorazepam 5 mg p/o every 4 hours (Day 3 and Day 4), Lorazepam 2,5 mg po every 4 hours (Day 5, Day 6) |
| Control | Active comparator | Drug: Naltrexone, Drug: Clonidine, Drug: LorazepamOpioid antagonist induction. Day 4. Duration 12-16 hours. Naltrexone single dose 12,5 mg p/o Correction of symptoms for opioid abstinence: Clonidine 150 µg p/o every 4 hours (Day 3 and Day 4) Lorazepam 5 mg p/o every 4 hours (Day 3 and Day 4), Lorazepam 2,5 mg po every 4 hours (Day 5, Day 6) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Opiate addiction
- Use of short-acting opiate (morphine or heroine)
- Age > 18 years
- Length of opiate addiction > 1 year
- Patient can make a decision for detoxification and has a capacity to consent for procedure
Key exclusion criteria (14 listed)
- Polyvalent addiction
- Pregnancy or breast feeding
- Cardiovascular pathology
- Acute or chronic kidney disease
- Decompensated liver pathology (jaundice, ascites, hepatic encephalopathy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaltrexoneAlso: Vivitrol, Revia | Drug | Control, Intervention |
| ClonidineAlso: Catapres, Kapvay | Drug | Control, Intervention |
| LorazepamAlso: Ativan | Drug | Control, Intervention |
Primary outcome
Cortisol levels
Time frame: 2 days
Cortisol levels were assessed 4 times starting on intervention day (1 hour before intervention, 1, 5 and 23 hours post-intervention)
Adrenocorticotropic hormone (ACTH) levels
Time frame: 2 days
Cortisol levels were assessed 4 times starting on intervention day (1 hour before intervention, 1, 5 and 23 hours post-intervention)
10 secondary outcomes
Stress response levels according to heart rate
Time frame: 4 days
Stress response levels according to respiratory rate
Time frame: 4 days
Stress response levels according to blood pressure
Time frame: 4 days
Changes of potassium concentration due to stress response
Time frame: 4 days
Changes of sodium concentration due to stress response
Time frame: 4 days
Changes of chloride concentration due to stress response
Time frame: 4 days
Changes of magnesium concentration due to stress response
Time frame: 4 days
Changes of glucose concentration due to stress response
Time frame: 4 days
Subjective Opiate Withdrawal Scale (SOWS)
Time frame: 4 days
Objective Opiate Withdrawal Scale (OOWS)
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ROBERTAS BADARAS, MD principal investigator
Vilnius University Clinic of Anaesthesiology and Intensive Care
JUOZAS IVASKEVICIUS, PROFESSOR study director
Vilnius University Clinic of Anaesthesiology and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naltrexone, Clonidine and Lorazepam in people with Opiate Addiction, run by Vilnius University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortisol levels (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2015; AzTrials last refreshed its copy on 7 Nov 2026.