Opiate DependencePhase 2NCT00332228
Behavioral Naltrexone Therapy: A Novel Treatment for Heroin Dependence
A Phase 2 study testing depot naltrexone, Compliance enhancement (CE) and BNT in people with Opiate Dependence, run by New York State Psychiatric Institute at 2 sites in United States.
Trial summary
The overall goal of this research project is to test the efficacy of a newly developed therapy, Behavioral Naltrexone Therapy (BNT), to enhance the success of naltrexone maintenance and long-term abstinence for individuals with heroin dependence. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Opiate Dependence
- What is being tested?
- depot naltrexone, Compliance enhancement (CE) and BNT
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2002to Dec 2007
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult, aged 18-60. Clinical Interview.
- Meets DSM-IV criteria for current opiate dependence disorder, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear. If participating as an outpatient only, recent opiate dependence must be confirmed by clinical history and/or communication with former treatment provider.
- Clinical and SCID interview. Urine toxicology. Naloxone Challenge (see Procedures) Communication with former treatment provider.
- Able to give informed consent. Clinical interview and mental status exam
- There must be one qualified significant other who is willing to be interviewed and participate in program in order for a subject to be included in the study.
- Clinical interview, and statement by significant other.
Who cannot join
- Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
- Clinical Interview, physical examination, serum pregnancy test
- Active medical illness which might make participation hazardous, such as untreated hypertension, acute hepatitis with SGOT or SGPT levels >2-3 times normal, unstable diabetes, chronic organic mental disorder (e.g., AIDS dementia).
- Clinical Interview, physical examination, laboratory (Chem-20, CBC, urinalysis), ECG
- Active psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-IV schizophrenia, bipolar disorder with mania or psychosis, and depressive disorder with suicide risk or 1 or more suicide attempts within the past year.
- Clinical and SCID interview, clinical mental status examination, discussions with previous psychiatrist or treatment provider if formerly in treatment.
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- History of allergic reaction to buprenorphine, naloxone, naltrexone, clonidine, or clonazepam.
- Clinical Interview
- Currently prescribed or regularly taking opiates for chronic pain or medical illness.
- Clinical Interview
- Current participation in another intensive substance abuse treatment program.
- Clinical Interview
- Current participation in a methadone maintenance treatment program and/or regular use of illicit methadone (>30 mg per week). Clinical Interview; Urine toxicology.
- Only available significant other is an active substance abuser, has an active psychiatric or medical illness which would interfere with participation (e.g., chronic psychosis, depression with suicide risk), or has a history of significant physical violence with the participant.
- Clinical Interview
- History of accidental drug overdose in the last three years as defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.
- Clinical Interview
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York State Psychiatric Institute
New York, New York, 10032
STARS
New York, New York, 10032
About this study
Official title: Study Behavioral Naltrexone Therapy: A Novel Treatment for Heroin Dependence
The overall goal of this research project is to test the efficacy of a newly developed therapy, Behavioral Naltrexone Therapy (BNT), to enhance the success of naltrexone maintenance and long-term abstinence for individuals with heroin dependence. This study includes free detox and outpatient treatment for opioid dependence that includes medication and a behavioral intervention.
Read the detailed description
The goal of this Stage II project is to test the efficacy of a new combination of behavioral therapy with oral naltrexone maintenance for the treatment of heroin addiction, and to test a new long-acting depot parenteral formulation of naltrexone in initiating treatment.
- Outpatient treatment with Behavioral Naltrexone Therapy will yield a lower rate of relapse to illicit opiates compared to naltrexone plus compliance enhancement therapy. Hypotheses:
- Injections of depot naltrexone will reduce early attrition, improve initial stabilization on oral naltrexone, and improve long-term outcome, particularly when combined with Behavioral Naltrexone Therapy.
- Patients who exhibit escalating levels of commitment language strength throughout one early session of BNT will remain in treatment longer, will take more doses of naltrexone, and will provide a higher percentage of opiate-free urines.
- Increased commitment language strength on the part of the SO monitor will contribute independently to the outcome of the identified patient, when controlling for patient level commitment.
A critical objective of this current proposal is to improve retention, particularly in the initial weeks of treatment. Preliminary work with a new depot formulation of naltrexone was conducted (Comer et al, 1999, unpublished data), showing that it is well tolerated and provides therapeutic blood levels and blockade of opiate effects for up to four weeks after a single injection. By removing the option of stopping naltrexone to sample heroin, a common mode of relapse, we hope to prevent early attrition and fully expose all patients to the behavioral regimen of BNT, intended to shape strong compliance with oral naltrexone and motivation for abstinence and lifestyle change.
160 heroin-dependent individuals seeking treatment will be recruited at PI (STARS) or referred from other sites (e.g., private physician; other detoxification programs). Prospective patients will be offered hospitalization for detoxification for rapid transition to naltrexone followed by outpatient naltrexone maintenance and counseling for six months. All enrolled participants will be encouraged to return for follow-up assessment visits at one, three, and six months beyond the completion of their participation for research purposes.
Patients will be randomly assigned to either the newly developed BNT or Compliance Enhancement Therapy (CET), a manual-guided approach developed by Carroll and O'Malley at Yale University as a control condition for psychotherapy studies with substance dependent patients. Patients will also be randomly assigned to receive either active or placebo injections of depot naltrexone prior to discharge from the detoxification. Therefore, there will be four treatment conditions with 40 participants per condition. These four conditions include: 1) BNT plus two doses of depot naltrexone prior to hospital discharge; 2) BNT plus two placebo injections; 3) Compliance Enhancement (CE), simulating standard treatment with oral naltrexone plus two depot naltrexone injections; and 4) CE plus two placebo injections.
- Conditions
- Opiate Dependence
- Being tested
- depot naltrexone, Compliance enhancement (CE), BNT
- Keywords
- opiate dependence, heroin dependence, naltrexone, cognitive behavioral therapy
- Medical subject headings
- Opioid-Related Disorders, Heroin Dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
depot naltrexoneDrug
long-acting depot parenteral formulation of naltrexone
Compliance enhancement (CE)Behavioural
Compliance enhancement (CE), simulating standard treatment with oral naltrexone
BNTDrug
behavioral therapy with oral naltrexone maintenance for the treatment of heroin addiction
| Study group | Role | What they receive |
|---|---|---|
| CE plus oral +depot naltrexone | Active comparator | Compliance enhancement (CE), simulating standard treatment with oral naltrexone plus two depot naltrexone; Receives: Drug: depot naltrexone; Behavioral: Compliance enhancement (CE) |
| CE plus oral naltrexone+ placebo | Placebo comparator | CE with oral naltrexone plus two placebo injections Receives: Behavioral: Compliance enhancement (CE) |
| BNT plus Depot naltrexone | Experimental | BNT plus two doses of depot naltrexone prior to hospital discharge Receives: Drug: depot naltrexone; Drug: BNT |
| BNT plus PBO injection | Placebo comparator | BNT plus two placebo injections Receives: Drug: BNT |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients relapsing to illicit opiates based on urine toxicology and self report.
proportion of patients relapsing to opiate use
Measured: over 6 months of trial or length of participation
proportion of patients retained in treatment
proportion of patients retained over the course of the trial
Measured: over course of 6 months of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2006 (estimated)
- Study startJun 2002
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Edward Nunes, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332228
- Sponsor's protocol ID
- 5004-R
- Other IDs
- R01DA010746
- Status last verified
- Oct 2012
- First submitted
- 30 May 2006
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Behavioral Naltrexone Therapy: A Novel Treatment for Heroin Dependence
- ClinicalTrials.gov ID
- NCT00332228
- Acronym / sponsor ID
- 5004-R
- Conditions
- Opiate Dependence
- Keywords
- opiate dependence, heroin dependence, naltrexone, cognitive behavioral therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2002
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 1 Jun 2006 (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 overall goal of this research project is to test the efficacy of a newly developed therapy, Behavioral Naltrexone Therapy (BNT), to enhance the success of naltrexone maintenance and long-term abstinence for individuals with heroin dependence. This study includes free detox and outpatient treatment for opioid dependence that includes medication and a behavioral intervention.
Detailed description
The goal of this Stage II project is to test the efficacy of a new combination of behavioral therapy with oral naltrexone maintenance for the treatment of heroin addiction, and to test a new long-acting depot parenteral formulation of naltrexone in initiating treatment.
- Outpatient treatment with Behavioral Naltrexone Therapy will yield a lower rate of relapse to illicit opiates compared to naltrexone plus compliance enhancement therapy. Hypotheses:
- Injections of depot naltrexone will reduce early attrition, improve initial stabilization on oral naltrexone, and improve long-term outcome, particularly when combined with Behavioral Naltrexone Therapy.
- Patients who exhibit escalating levels of commitment language strength throughout one early session of BNT will remain in treatment longer, will take more doses of naltrexone, and will provide a higher percentage of opiate-free urines.
- Increased commitment language strength on the part of the SO monitor will contribute independently to the outcome of the identified patient, when controlling for patient level commitment.
A critical objective of this current proposal is to improve retention, particularly in the initial weeks of treatment. Preliminary work with a new depot formulation of naltrexone was conducted (Comer et al, 1999, unpublished data), showing that it is well tolerated and provides therapeutic blood levels and blockade of opiate effects for up to four weeks after a single injection. By removing the option of stopping naltrexone to sample heroin, a common mode of relapse, we hope to prevent early attrition and fully expose all patients to the behavioral regimen of BNT, intended to shape strong compliance with oral naltrexone and motivation for abstinence and lifestyle change.
160 heroin-dependent individuals seeking treatment will be recruited at PI (STARS) or referred from other sites (e.g., private physician; other detoxification programs). Prospective patients will be offered hospitalization for detoxification for rapid transition to naltrexone followed by outpatient naltrexone maintenance and counseling for six months. All enrolled participants will be encouraged to return for follow-up assessment visits at one, three, and six months beyond the completion of their participation for research purposes.
Patients will be randomly assigned to either the newly developed BNT or Compliance Enhancement Therapy (CET), a manual-guided approach developed by Carroll and O'Malley at Yale University as a control condition for psychotherapy studies with substance dependent patients. Patients will also be randomly assigned to receive either active or placebo injections of depot naltrexone prior to discharge from the detoxification. Therefore, there will be four treatment conditions with 40 participants per condition. These four conditions include: 1) BNT plus two doses of depot naltrexone prior to hospital discharge; 2) BNT plus two placebo injections; 3) Compliance Enhancement (CE), simulating standard treatment with oral naltrexone plus two depot naltrexone injections; and 4) CE plus two placebo injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CE plus oral +depot naltrexone | Active comparator | Drug: depot naltrexone, Behavioral: Compliance enhancement (CE)Compliance enhancement (CE), simulating standard treatment with oral naltrexone plus two depot naltrexone; |
| CE plus oral naltrexone+ placebo | Placebo comparator | Behavioral: Compliance enhancement (CE)CE with oral naltrexone plus two placebo injections |
| BNT plus Depot naltrexone | Experimental | Drug: depot naltrexone, Drug: BNTBNT plus two doses of depot naltrexone prior to hospital discharge |
| BNT plus PBO injection | Placebo comparator | Drug: BNTBNT plus two placebo injections |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult, aged 18-60. Clinical Interview.
- Meets DSM-IV criteria for current opiate dependence disorder, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear. If participating as an outpatient only, recent opiate dependence must be confirmed by clinical history and/or communication with former treatment provider.
- Clinical and SCID interview. Urine toxicology. Naloxone Challenge (see Procedures) Communication with former treatment provider.
- Able to give informed consent. Clinical interview and mental status exam
- There must be one qualified significant other who is willing to be interviewed and participate in program in order for a subject to be included in the study.
Key exclusion criteria (17 listed)
- Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
- Clinical Interview, physical examination, serum pregnancy test
- Active medical illness which might make participation hazardous, such as untreated hypertension, acute hepatitis with SGOT or SGPT levels >2-3 times normal, unstable diabetes, chronic organic mental disorder (e.g., AIDS dementia).
- Clinical Interview, physical examination, laboratory (Chem-20, CBC, urinalysis), ECG
- Active psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-IV schizophrenia, bipolar disorder with mania or psychosis, and depressive disorder with suicide risk or 1 or more suicide attempts within the past year.
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 |
|---|---|---|
| depot naltrexonelong-acting depot parenteral formulation of naltrexone | Drug | BNT plus Depot naltrexone, CE plus oral +depot naltrexone |
| Compliance enhancement (CE)Compliance enhancement (CE), simulating standard treatment with oral naltrexone | Behavioural | CE plus oral +depot naltrexone, CE plus oral naltrexone+ placebo |
| BNTbehavioral therapy with oral naltrexone maintenance for the treatment of heroin addiction | Drug | BNT plus Depot naltrexone, BNT plus PBO injection |
Primary outcome
proportion of patients relapsing to illicit opiates based on urine toxicology and self report.
Time frame: over 6 months of trial or length of participation
proportion of patients relapsing to opiate use
proportion of patients retained in treatment
Time frame: over course of 6 months of trial
proportion of patients retained over the course of the trial
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 26 Oct 2012.
- serive websiteLink provided by the sponsor.
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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.
Edward Nunes, MD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing depot naltrexone, Compliance enhancement (CE) and BNT in people with Opiate Dependence, run by New York State Psychiatric Institute at 2 sites 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 6 inclusion and 17 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 26 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
proportion of patients relapsing to illicit opiates based on urine toxicology and self report. (time frame: over 6 months of trial or length of participation). 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 26 Oct 2012; AzTrials last refreshed its copy on 7 Nov 2026.