Heroin DependencePhase 2NCT00135759
Addition of Naltrexone to Methadone Taper
A Phase 2 study testing Naltrexone in people with Heroin Dependence and Opioid-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
There is a continuing search for more effective opiate detoxification treatments. This study's purpose is to investigate the effects of adding very low doses of naltrexone to a methadone tapering treatment in opioid dependent individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heroin Dependence, Opioid-Related Disorders, Substance-Related Disorders
- What is being tested?
- Naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Jul 2006
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current DSM-IV diagnosis of opiate dependence
- Reads and understands English
Who cannot join
- Serious medical disorders (e.g., uncontrolled hypertension, acute or chronic active hepatitis, kidney failure, uncontrolled diabetes)
- Psychiatric conditions that require intensive services (e.g., depression with suicidal ideation, psychosis)
- Mental retardation or other disorder that might limit ability to give informed consent
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Place of Low-Dose Naltrexone in Opiate Detoxification
There is a continuing search for more effective opiate detoxification treatments. This study's purpose is to investigate the effects of adding very low doses of naltrexone to a methadone tapering treatment in opioid dependent individuals.
Read the detailed description
Although many different techniques for opiate detoxification exist, the search continues for more effective approaches to reduce the duration and discomfort associated with opioid withdrawal. It has been shown that very low doses of naltrexone administered in the presence of opiates has analgesic and dependency reducing properties. The purpose of this study is to investigate the effects of very low doses of naltrexone administered during a methadone tapering schedule for opiate detoxification. In addition, this study will compare the effectiveness of two different dose regimens of naltrexone.
Participants in this double-blind study will be recruited among opioid dependent individuals already enrolled in a 6-day inpatient opioid detoxification program. Participants will be already receiving standard treatment to control discomfort during a methadone tapering schedule. Participants will be randomly assigned to one of three groups. Two of the groups will be given naltrexone; Group 1 will receive 0.125 mg each day, and Group 2 will receive 0.250 mg each day. Group 3 will receive a placebo. Participants will be evaluated upon enrollment for opiate addiction severity. They will continue to be evaluated daily for signs of withdrawal and salivary cortisol. An additional evaluation and urine test will be completed 1 day following discharge. Daily evaluations will take 15 minutes to complete. Seven days following discharge, participants will be contacted for a 20-minute phone interview. During the phone interview, participants will schedule an appointment to provide a final urine specimen for the detection of drugs of abuse.
- Being tested
- Naltrexone, Placebo comparator
- Keywords
- opiate dependence
- Medical subject headings
- Heroin Dependence, Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
low dose naltrexone in addition to daily methadone taper
Placebo comparatorDrug
1 capsule/day for 6 days
naltrexoneDrug
0.125 mg capsule/day for 6 days
naltrexoneDrug
0.250 mg capsule/day for 6 days
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | Drug Receives: Drug: Placebo comparator |
| 2 | Experimental | experimental Receives: Drug: Naltrexone |
| 3 | Experimental | experimental Receives: Drug: Naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Withdrawal intensity
Measured: 6 days
Secondary outcomes (1)
Retention in treatment
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startApr 2005
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heroin DependenceStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Paolo Mannelli, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135759
- Sponsor's protocol ID
- NIDA-15469-1
- Other IDs
- R21-15469-1, DPMC
- Status last verified
- Aug 2008
- First submitted
- 23 Aug 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mannelli P, Wu LT, Peindl KS, Gorelick DA. Smoking and opioid detoxification: behavioral changes and response to treatment. Nicotine Tob Res. 2013 Oct;15(10):1705-13. doi: 10.1093/ntr/ntt046. Epub 2013 Apr 9.
PubMed 23572466Mannelli P, Peindl K, Wu LT, Patkar AA, Gorelick DA. The combination very low-dose naltrexone-clonidine in the management of opioid withdrawal. Am J Drug Alcohol Abuse. 2012 May;38(3):200-5. doi: 10.3109/00952990.2011.644003. Epub 2012 Jan 10.
PubMed 22233189Mannelli P, Peindl K, Patkar AA, Wu LT, Tharwani HM, Gorelick DA. Problem drinking and low-dose naltrexone-assisted opioid detoxification. J Stud Alcohol Drugs. 2011 May;72(3):507-13. doi: 10.15288/jsad.2011.72.507.
PubMed 21513688Mannelli P, Peindl K, Patkar AA, Wu LT, Pae CU, Gorelick DA. Reduced cannabis use after low-dose naltrexone addition to opioid detoxification. J Clin Psychopharmacol. 2010 Aug;30(4):476-8. doi: 10.1097/JCP.0b013e3181e5c168. No abstract available.
PubMed 20631574Mannelli P, Patkar AA, Peindl K, Gottheil E, Wu LT, Gorelick DA. Early outcomes following low dose naltrexone enhancement of opioid detoxification. Am J Addict. 2009 Mar-Apr;18(2):109-16. doi: 10.1080/10550490902772785.
PubMed 19283561
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Place of Low-Dose Naltrexone in Opiate Detoxification
- ClinicalTrials.gov ID
- NCT00135759
- Acronym / sponsor ID
- NIDA-15469-1
- Keywords
- opiate dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Apr 2005
- Study completion
- Jul 2006 (actual)
- First posted
- 26 Aug 2005 (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.
There is a continuing search for more effective opiate detoxification treatments. This study's purpose is to investigate the effects of adding very low doses of naltrexone to a methadone tapering treatment in opioid dependent individuals.
Detailed description
Although many different techniques for opiate detoxification exist, the search continues for more effective approaches to reduce the duration and discomfort associated with opioid withdrawal. It has been shown that very low doses of naltrexone administered in the presence of opiates has analgesic and dependency reducing properties. The purpose of this study is to investigate the effects of very low doses of naltrexone administered during a methadone tapering schedule for opiate detoxification. In addition, this study will compare the effectiveness of two different dose regimens of naltrexone.
Participants in this double-blind study will be recruited among opioid dependent individuals already enrolled in a 6-day inpatient opioid detoxification program. Participants will be already receiving standard treatment to control discomfort during a methadone tapering schedule. Participants will be randomly assigned to one of three groups. Two of the groups will be given naltrexone; Group 1 will receive 0.125 mg each day, and Group 2 will receive 0.250 mg each day. Group 3 will receive a placebo. Participants will be evaluated upon enrollment for opiate addiction severity. They will continue to be evaluated daily for signs of withdrawal and salivary cortisol. An additional evaluation and urine test will be completed 1 day following discharge. Daily evaluations will take 15 minutes to complete. Seven days following discharge, participants will be contacted for a 20-minute phone interview. During the phone interview, participants will schedule an appointment to provide a final urine specimen for the detection of drugs of abuse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Drug: Placebo comparatorDrug |
| 2 | Experimental | Drug: Naltrexoneexperimental |
| 3 | Experimental | Drug: Naltrexoneexperimental |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Current DSM-IV diagnosis of opiate dependence
- Reads and understands English
Key exclusion criteria (4 listed)
- Serious medical disorders (e.g., uncontrolled hypertension, acute or chronic active hepatitis, kidney failure, uncontrolled diabetes)
- Psychiatric conditions that require intensive services (e.g., depression with suicidal ideation, psychosis)
- Mental retardation or other disorder that might limit ability to give informed consent
- Pregnant
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 |
|---|---|---|
| Naltrexonelow dose naltrexone in addition to daily methadone taper | Drug | 2, 3 |
| Placebo comparator1 capsule/day for 6 days | Drug | Group 1 |
| naltrexone0.125 mg capsule/day for 6 days | Drug | 2 |
| naltrexone0.250 mg capsule/day for 6 days | Drug | 3 |
Primary outcome
Withdrawal intensity
Time frame: 6 days
1 secondary outcome
Retention in treatment
Time frame: 6 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 Jan 2017.
- Derived from this study: PubMed 23572466Mannelli P, Wu LT, Peindl KS, Gorelick DA. Smoking and opioid detoxification: behavioral changes and response to treatment. Nicotine Tob Res. 2013 Oct;15(10):1705-13. doi: 10.1093/ntr/ntt046. Epub 2013 Apr 9.
- Derived from this study: PubMed 22233189Mannelli P, Peindl K, Wu LT, Patkar AA, Gorelick DA. The combination very low-dose naltrexone-clonidine in the management of opioid withdrawal. Am J Drug Alcohol Abuse. 2012 May;38(3):200-5. doi: 10.3109/00952990.2011.644003. Epub 2012 Jan 10.
- Derived from this study: PubMed 21513688Mannelli P, Peindl K, Patkar AA, Wu LT, Tharwani HM, Gorelick DA. Problem drinking and low-dose naltrexone-assisted opioid detoxification. J Stud Alcohol Drugs. 2011 May;72(3):507-13. doi: 10.15288/jsad.2011.72.507.
- Derived from this study: PubMed 20631574Mannelli P, Peindl K, Patkar AA, Wu LT, Pae CU, Gorelick DA. Reduced cannabis use after low-dose naltrexone addition to opioid detoxification. J Clin Psychopharmacol. 2010 Aug;30(4):476-8. doi: 10.1097/JCP.0b013e3181e5c168. No abstract available.
- Derived from this study: PubMed 19283561Mannelli P, Patkar AA, Peindl K, Gottheil E, Wu LT, Gorelick DA. Early outcomes following low dose naltrexone enhancement of opioid detoxification. Am J Addict. 2009 Mar-Apr;18(2):109-16. doi: 10.1080/10550490902772785.
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.
Paolo Mannelli, M.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naltrexone in people with Heroin Dependence and Opioid-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
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 2 inclusion and 4 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 Jan 2017. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Withdrawal intensity (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00135759, which also lists 5 linked publications.
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 Jan 2017.