Opioid DependencePhase 2/3DominoNCT01024335
Dronabinol Naltrexone Treatment for Opioid Dependence
A Phase 2/3 study testing injectable naltrexone and dronabinol in people with Opioid Dependence, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The goal of this two-year study is to test the efficacy of dronabinol as an adjunct to maintenance treatment with naltrexone in opioid-dependent individuals. We hypothesize that administering dronabinol during detoxification and during the first few weeks of naltrexone treatment will lead to improved naltrexone… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- injectable naltrexone and dronabinol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2012
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 1. Adult, aged 18-60.
- 2. Meets Diagnostic and Statistical Manual -IV criteria for current opiate dependence disorder of at least six months duration, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear.
- 3. Have a history of marijuana use (more than 30 occasions lifetime)
- 4. Voluntarily seeking treatment for opioid dependence
- 5. In otherwise good health based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests (hematology, blood chemistry, urinalysis) within normal ranges.
- 6. Able to give informed consent.
Who cannot join
- 1. Physiologically dependent on alcohol or sedative-hypnotics with impending withdrawal.
- 2. Patients meeting current criteria for cannabis abuse or dependence, and those who used cannabis in the week prior to study entry as documented by the positive toxicology
- 3. Current Diagnostic and Statistical Manual -IV criteria of other substance use disorders. Exceptions include cannabis abuse or dependence, nicotine dependence, cocaine abuse or dependence, alcohol abuse or alcohol dependence without physiological dependence as long as opioid dependence is a primary disorder. Alcohol dependence with physiological dependence is exclusionary.
- 4. Significant current suicidal risk or 1 or more suicide attempts within the past year
- 5. History of accidental drug overdose in the last three years defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.
- 6. Positive serum pregnancy test, lactation, or unwillingness to use a satisfactory method of birth control
Show all 13Show fewer
- 7. Active psychiatric disorder which might interfere with participation or make participation hazardous, including Diagnostic and Statistical Manual -IV organic mental disorder, psychotic disorder, or bipolar disorder with mania
- 8. History of allergic reaction, adverse reaction, or sensitivity to any study medication.
- 9. Acute hepatitis with serum glutamic-oxaloacetic transaminase or serum glutamic-pyruvic transaminase > 3 times the upper end of the laboratory normal range (chronic hepatitis is acceptable as we have found naltrexone treatment well tolerate and safe among patients with chronic hepatitis)
- 10. Currently prescribed or regularly taking opiates for chronic pain or medical illness.
- 11. Current participation in a methadone maintenance treatment program and/or regular use of illicit methadone (>30 mg per week).
- 12. Current participation in another intensive psychotherapy or substance abuse treatment program or participation in another treatment study.
- 13. Concurrent treatment with psychotropic medications
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
The goal of this two-year study is to test the efficacy of dronabinol as an adjunct to maintenance treatment with naltrexone in opioid-dependent individuals. We hypothesize that administering dronabinol during detoxification and during the first few weeks of naltrexone treatment will lead to improved naltrexone tolerability, resulting in better naltrexone compliance and treatment retention, and ultimately a reduction in opioid use and relapse rates.
Read the detailed description
The goal of this two-year study is to test the efficacy of dronabinol as an adjunct to maintenance treatment with naltrexone in opioid-dependent individuals. We are proposing a randomized, double-blind, placebo controlled, parallel-groups, 8 week study of relapse prevention in opioid-dependent individuals. Participants will be randomized into one of two conditions (1) Naltrexone and Placebo (N=20) and (2) Naltrexone and dronabinol 15 mg bid (N=40). Treatment will be delivered in an outpatient setting except for the initial phase of inpatient detoxification, lasting 8 days. A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections), while dronabinol or placebo will be taken daily. In addition, patients will receive a psychosocial intervention that will include elements of motivational interviewing and cognitive-behavioral relapse prevention therapy. The primary aim is to test the efficacy of dronabinol in improving tolerability of naltrexone induction and reducing attrition during detoxification and the first two months of naltrexone treatment. The primary outcome will be the severity of opiate withdrawal and craving. The secondary outcome will be will be retention in treatment at study's end.
- Conditions
- Opioid Dependence
- Being tested
- injectable naltrexone and dronabinol, Naltrexone and placebo
- Keywords
- opioid dependence, naltrexone, vivitrol, dronabinol, marinol
- 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.
injectable naltrexone and dronabinolDrug
Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment.
Naltrexone and placeboDrug
Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone and placebo | Active comparator | A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment. Receives: Drug: Naltrexone and placebo |
| Naltrexone and dronabinol | Experimental | A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment. Receives: Drug: injectable naltrexone and dronabinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opiate Withdrawal Measured by the Subjective Opiate Withdrawal Scale (SOWS) .
The Subjective Opiate Withdrawal Scale is a self-administered 16 scale containing 16 symptoms ranging in severity from 0 (not at all) to 4 (extremely). The SOWS total score is the sum of 16 items, ranging from 0 (no opiate withdrawal ) to 64 ( severe opiate withdrawal). Values from multiple assessments during the 8-week outpatient phase were averaged.
Measured: 3x/week during 8 weeks of the trial or study participation
Retention
Of those participants randomized to the naltrexone and dronabinol arm, the number that completed all 8 weeks of treatment.
Measured: retention over 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 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
- Principal investigator, Adam Bisaga, National Institute on Drug Abuse (NIDA)
- Investigators
- Adam Bisaga, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024335
- Sponsor's protocol ID
- #5962 DA027124
- Other IDs
- R01DA027124, DPMC
- Acronym
- Domino
- Status last verified
- May 2018
- First submitted
- 30 Nov 2009
- Last updated
- 18 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dronabinol Naltrexone Treatment for Opioid Dependence
- ClinicalTrials.gov ID
- NCT01024335
- Acronym / sponsor ID
- Domino / #5962 DA027124
- Conditions
- Opioid Dependence
- Keywords
- opioid dependence, naltrexone, vivitrol, dronabinol, marinol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Posted 5 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this two-year study is to test the efficacy of dronabinol as an adjunct to maintenance treatment with naltrexone in opioid-dependent individuals. We hypothesize that administering dronabinol during detoxification and during the first few weeks of naltrexone treatment will lead to improved naltrexone tolerability, resulting in better naltrexone compliance and treatment retention, and ultimately a reduction in opioid use and relapse rates.
Detailed description
The goal of this two-year study is to test the efficacy of dronabinol as an adjunct to maintenance treatment with naltrexone in opioid-dependent individuals. We are proposing a randomized, double-blind, placebo controlled, parallel-groups, 8 week study of relapse prevention in opioid-dependent individuals. Participants will be randomized into one of two conditions (1) Naltrexone and Placebo (N=20) and (2) Naltrexone and dronabinol 15 mg bid (N=40). Treatment will be delivered in an outpatient setting except for the initial phase of inpatient detoxification, lasting 8 days. A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections), while dronabinol or placebo will be taken daily. In addition, patients will receive a psychosocial intervention that will include elements of motivational interviewing and cognitive-behavioral relapse prevention therapy. The primary aim is to test the efficacy of dronabinol in improving tolerability of naltrexone induction and reducing attrition during detoxification and the first two months of naltrexone treatment. The primary outcome will be the severity of opiate withdrawal and craving. The secondary outcome will be will be retention in treatment at study's end.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone and placebo | Active comparator | Drug: Naltrexone and placeboA long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment. |
| Naltrexone and dronabinol | Experimental | Drug: injectable naltrexone and dronabinolA long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 1. Adult, aged 18-60.
- 2. Meets Diagnostic and Statistical Manual -IV criteria for current opiate dependence disorder of at least six months duration, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear.
- 3. Have a history of marijuana use (more than 30 occasions lifetime)
- 4. Voluntarily seeking treatment for opioid dependence
- 5. In otherwise good health based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests (hematology, blood chemistry, urinalysis) within normal ranges.
Key exclusion criteria (13 listed)
- 1. Physiologically dependent on alcohol or sedative-hypnotics with impending withdrawal.
- 2. Patients meeting current criteria for cannabis abuse or dependence, and those who used cannabis in the week prior to study entry as documented by the positive toxicology
- 3. Current Diagnostic and Statistical Manual -IV criteria of other substance use disorders. Exceptions include cannabis abuse or dependence, nicotine dependence, cocaine abuse or dependence, alcohol abuse or alcohol dependence without physiological dependence as long as opioid dependence is a primary disorder. Alcohol dependence with physiological dependence is exclusionary.
- 4. Significant current suicidal risk or 1 or more suicide attempts within the past year
- 5. History of accidental drug overdose in the last three years defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.
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 |
|---|---|---|
| injectable naltrexone and dronabinolInjectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment. | Drug | Naltrexone and dronabinol |
| Naltrexone and placeboInjectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks. | Drug | Naltrexone and placebo |
Primary outcome
Opiate Withdrawal Measured by the Subjective Opiate Withdrawal Scale (SOWS) .
Time frame: 3x/week during 8 weeks of the trial or study participation
The Subjective Opiate Withdrawal Scale is a self-administered 16 scale containing 16 symptoms ranging in severity from 0 (not at all) to 4 (extremely). The SOWS total score is the sum of 16 items, ranging from 0 (no opiate withdrawal ) to 64 ( severe opiate withdrawal). Values from multiple assessments during the 8-week outpatient phase were averaged.
Retention
Time frame: retention over 8 weeks.
Of those participants randomized to the naltrexone and dronabinol arm, the number that completed all 8 weeks of treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Adam Bisaga, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing injectable naltrexone and dronabinol in people with Opioid Dependence, run by New York State Psychiatric Institute 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 6 inclusion and 13 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 18 Jun 2018. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Opiate Withdrawal Measured by the Subjective Opiate Withdrawal Scale (SOWS) . (time frame: 3x/week during 8 weeks of the trial or study 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 18 Jun 2018.