Heroin DependencePhase 2NCT00218127
Treatment of Opioid/Heroin Dependence: Comparison of Three Medication Dosing Regimens
A Phase 2 study testing Levoacetyl Methadol 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
Heroin dependence remains a major addiction problem in the United States. The purpose of this study is to determine the effectiveness of levoacetyl methadol (ORLAAM) in treating heroin dependent individuals. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Heroin Dependence, Opioid-Related Disorders
- What is being tested?
- Levoacetyl Methadol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Jul 2005
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current opiate dependence
- Provides acceptable proof of identity
- History of 5 or more years of regular heroin use or dependence
- Reads and writes English
Who cannot join
- Significant suicidal or homicidal ideation, intent, or plan
- Current AXIS I psychotic, depressive, or anxiety disorder
- Meets DSM-IV criteria for dependence on any drug other than nicotine
- Impending legal complications or incarceration
- On parole or probation that requires reports of drug use or research data
- Currently receiving treatment for opiate dependence
Show all 12Show fewer
- Currently participating in a 12-step substance detoxification program
- Medical condition that contraindicates administration of ORLAAM
- Plans to leave Houston, Texas within the year following study entry
- Pregnant or breastfeeding
- History of heart problems, including heart arrhythmias
- Requires psychotropic medications (e.g., antidepressants, antipsychotics, anxiolytics)
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Psychatiry, Mental Services
Houston, Texas, 77030
About this study
Official title: Opioid Maintenance: Optimum Stabilization and Withdrawal
Heroin dependence remains a major addiction problem in the United States. The purpose of this study is to determine the effectiveness of levoacetyl methadol (ORLAAM) in treating heroin dependent individuals.
Read the detailed description
Heroin is a highly addictive drug, and its abuse has both medical and social consequences. ORLAAM is approved to treat both opiate and narcotic dependence. The purpose of this study is to determine the efficacy of ORLAAM in treating heroin dependent individuals. In addition, this study will determine the most effective dosing regimen of ORLAAM.
This study will last 20 weeks. Participants will be randomly assigned to receive one of three dosing conditions: 1) standard fixed dose, 2) dose-by-weight, and 3) dose effect. The dose effect condition will include a dose of ORLAAM dependent on opiate use and withdrawal symptoms associated with opiate use; doses may be adjusted throughout the study. All participants will receive cognitive behavioral therapy throughout the study.
- Conditions
- Heroin Dependence, Opioid-Related Disorders
- Being tested
- Levoacetyl Methadol
- Keywords
- Heroin dependence
- Medical subject headings
- Heroin Dependence, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levoacetyl MethadolDrug
Also called LAAM
WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day
Levoacetyl MethadolDrug
Also called LAAM
MaxEffect+CBT evaluation to 48 mg Adjust to effect (+/-)
Levoacetyl MethadolDrug
Also called LAAM
LAAM Fixed Dose evaluation up to 48 mg 48 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | LAAM WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day for 20 weeks Receives: Drug: Levoacetyl Methadol |
| 2 | Experimental | LAAM MaxEffect to 48 mg Adjust to effect (+/-) Receives: Drug: Levoacetyl Methadol |
| 3 | Experimental | LAAM Fixed Dose up to 48 mg 48 mg Receives: Drug: Levoacetyl Methadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
drug use
Measured: herion use over 20 week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2001
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- John Grabowski, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218127
- Sponsor's protocol ID
- NIDA-13664-1
- Other IDs
- R01-13664-1, DPMC
- Status last verified
- Oct 2016
- First submitted
- 16 Sep 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
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
- Opioid Maintenance: Optimum Stabilization and Withdrawal
- ClinicalTrials.gov ID
- NCT00218127
- Acronym / sponsor ID
- NIDA-13664-1
- Conditions
- Heroin Dependence, Opioid-Related Disorders
- Keywords
- Heroin dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Nov 2001
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 22 Sep 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.
Heroin dependence remains a major addiction problem in the United States. The purpose of this study is to determine the effectiveness of levoacetyl methadol (ORLAAM) in treating heroin dependent individuals.
Detailed description
Heroin is a highly addictive drug, and its abuse has both medical and social consequences. ORLAAM is approved to treat both opiate and narcotic dependence. The purpose of this study is to determine the efficacy of ORLAAM in treating heroin dependent individuals. In addition, this study will determine the most effective dosing regimen of ORLAAM.
This study will last 20 weeks. Participants will be randomly assigned to receive one of three dosing conditions: 1) standard fixed dose, 2) dose-by-weight, and 3) dose effect. The dose effect condition will include a dose of ORLAAM dependent on opiate use and withdrawal symptoms associated with opiate use; doses may be adjusted throughout the study. All participants will receive cognitive behavioral therapy throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Levoacetyl MethadolLAAM WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day for 20 weeks |
| 2 | Experimental | Drug: Levoacetyl MethadolLAAM MaxEffect to 48 mg Adjust to effect (+/-) |
| 3 | Experimental | Drug: Levoacetyl MethadolLAAM Fixed Dose up to 48 mg 48 mg |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Current opiate dependence
- Provides acceptable proof of identity
- History of 5 or more years of regular heroin use or dependence
- Reads and writes English
Key exclusion criteria (12 listed)
- Significant suicidal or homicidal ideation, intent, or plan
- Current AXIS I psychotic, depressive, or anxiety disorder
- Meets DSM-IV criteria for dependence on any drug other than nicotine
- Impending legal complications or incarceration
- On parole or probation that requires reports of drug use or research data
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 |
|---|---|---|
| Levoacetyl MethadolAlso: LAAMWtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day | Drug | 1 |
| Levoacetyl MethadolAlso: LAAMMaxEffect+CBT evaluation to 48 mg Adjust to effect (+/-) | Drug | 2 |
| Levoacetyl MethadolAlso: LAAMLAAM Fixed Dose evaluation up to 48 mg 48 mg | Drug | 3 |
Primary outcome
drug use
Time frame: herion use over 20 week period
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.
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.
John Grabowski, PhD principal investigator
The University of Texas Health Science Center, Houston
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 Levoacetyl Methadol 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 4 inclusion and 12 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. 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?
drug use (time frame: herion use over 20 week period). 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 Jan 2017.