Cannabis DependencePhase 1/2NCT02088177
Study of Long-Acting Injectable Naltrexone to Treat Cannabis Dependence
A Phase 1/2 study testing Long-acting injectable naltrexone in people with Cannabis Dependence, run by New York State Psychiatric Institute at 2 sites in United States.
Trial summary
This is an 8 week, outpatient research study testing the use of long-acting naltrexone (Vivitrol) as a treatment for marijuana dependence. Vivitrol is a medication that is effective in treating dependence on opiates and opioids, and in treating dependence on alcohol. It is FDA approved for these disorders. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cannabis Dependence
- What is being tested?
- Long-acting injectable naltrexone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2014to Mar 2016
- Phase
- Phase 1/2
- 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
- Between the ages of 18 - 60 years
- Meets DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, edition IV-TR) criteria for cannabis dependence
- Seeking treatment for cannabis dependence
- Reports using cannabis an average of 5 days per week over the past 28 days
- Capable of giving informed consent and complying with study procedures
Who cannot join
- Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
- Currently meeting DSM-IV criteria for a psychiatric disorder that, according to the investigator's judgment, may require pharmacological or non-pharmacological intervention during the course of the study
- Receiving opioid analgesic medication
- Known history of allergy, intolerance, or hypersensitivity to naltrexone
- Pregnancy, lactation, or failure to use adequate contraceptive methods in female participants who are actively engaging in sexual activity with men
- Unstable medical conditions, such as poorly controlled hypertension or liver disease, which might make participation hazardous
Show all 11Show fewer
- Chronic pain conditions
- Liver dysfunction as indicated by elevated liver transaminases greater than 2 times the upper limit of normal
- Current DSM-IV diagnosis of substance dependence other than nicotine or cannabis dependence
- Legally mandated to participate in a substance use disorder treatment program
- Risk for suicide
Trial locations and contacts
2 sites in 1 country.
United States2 sites
STARS Downtown, Columbia-Presbyterian and New York State Psychiatric Institute
New York, New York, 10019
STARS clinic, Columbia-New York Presbyterian and New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Open-Label Pilot Study of Long-Acting Injectable Naltrexone Treatment for Cannabis Dependence
This is an 8 week, outpatient research study testing the use of long-acting naltrexone (Vivitrol) as a treatment for marijuana dependence. Vivitrol is a medication that is effective in treating dependence on opiates and opioids, and in treating dependence on alcohol. It is FDA approved for these disorders. It is a long-acting medication that contains enough medicine in each injection to last for one month. One way it works is by blocking the effects of opiates, including opiates released by the body in response to drugs and alcohol. In this study, we are interested in testing the effects of Vivitrol in people with marijuana dependence.
Individuals participating in this study will receive two Vivitrol injections, each given four weeks apart, (week 1 and week 5). The injection is given in the muscle of the buttock on one side. Participants will attend clinic visits two times a week during this 8-week study for medical management for drug use and for monitoring of physical and psychological health.
Read the detailed description
This is an 8 week, outpatient, open-label clinical trial of long-acting injectable naltrexone as a treatment for cannabis dependence.
The purpose of the study will be to evaluate marijuana use patterns and tolerability of long-acting naltrexone in 7 treatment-seeking, cannabis-dependent outpatients; also to assess feasibility of conducting a larger trial with this medication. Cannabis dependent patients will have twice weekly clinic visits where they will receive injections of Vivitrol four weeks apart, in Week 1 and in Week 5. The psychosocial intervention for this study will be Medical Management, designed to facilitate adherence to the study medication and monitoring procedures, as well as to support the participant in achieving his or her marijuana use goals.
Participants will self-report cannabis use, will provide urine toxicology for quantitative assessment of THC (Tetrahydrocannabinol, the active ingredient in marijuana), and will provide serum samples for safety monitoring, and will answer questionnaires and will report on their physical and psychological health weekly.
- Conditions
- Cannabis Dependence
- Being tested
- Long-acting injectable naltrexone
- Keywords
- Cannabis, Cannabis Dependence, Cannabis Use Disorder, Marijuana, Naltrexone, Long Acting Injectable Naltrexone, Treatment
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-acting injectable naltrexoneDrug
Also called Vivitrol
Vivitrol is a long-acting opioid antagonist which blocks opioid agonists from binding at opioid receptors. It be administered as described above.
| Study group | Role | What they receive |
|---|---|---|
| Long-acting injectable naltrexone | Experimental | Two doses of long-acting injectable naltrexone, 380 mg by intramuscular injection in the gluteal muscle at study day 1 and again between study days 28-30. Receives: Drug: Long-acting injectable naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Marijuana Use
Change in marijuana use, as measured by comparing the mean number of self reported days of marijuana use per week in the final study week, which will be week 8 or earlier if the participant discontinues as compared to the mean number of self reported days of marijuana use in week 1
Measured: Weeks 1 - 8
Number of Participants Receiving the Second Injection of Study Medication
The number of participants who accept the second injection at week 5 will be used as one measure of tolerability.
Measured: Weeks 1 - 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2016
- Study completionMar 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cannabis 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frances R Levin, New York State Psychiatric Institute
- Investigators
- Daniel P Notzon, M.D., Principal investigator, Columbia and NY Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088177
- Sponsor's protocol ID
- #6799
- Other IDs
- DA009236
- Status last verified
- Apr 2019
- First submitted
- 25 Feb 2014
- Last updated
- 24 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Johnson BA, Ait-Daoud N, Roache JD. The COMBINE SAFTEE: a structured instrument for collecting adverse events adapted for clinical studies in the alcoholism field. J Stud Alcohol Suppl. 2005 Jul;(15):157-67; discussion 140. doi: 10.15288/jsas.2005.s15.157.
PubMed 16223067
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Pilot Study of Long-Acting Injectable Naltrexone Treatment for Cannabis Dependence
- ClinicalTrials.gov ID
- NCT02088177
- Acronym / sponsor ID
- #6799
- Conditions
- Cannabis Dependence
- Keywords
- Cannabis, Cannabis Dependence, Cannabis Use Disorder, Marijuana, Naltrexone, Long Acting Injectable Naltrexone, Treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Posted 18 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an 8 week, outpatient research study testing the use of long-acting naltrexone (Vivitrol) as a treatment for marijuana dependence. Vivitrol is a medication that is effective in treating dependence on opiates and opioids, and in treating dependence on alcohol. It is FDA approved for these disorders. It is a long-acting medication that contains enough medicine in each injection to last for one month. One way it works is by blocking the effects of opiates, including opiates released by the body in response to drugs and alcohol. In this study, we are interested in testing the effects of Vivitrol in people with marijuana dependence.
Individuals participating in this study will receive two Vivitrol injections, each given four weeks apart, (week 1 and week 5). The injection is given in the muscle of the buttock on one side. Participants will attend clinic visits two times a week during this 8-week study for medical management for drug use and for monitoring of physical and psychological health.
Detailed description
This is an 8 week, outpatient, open-label clinical trial of long-acting injectable naltrexone as a treatment for cannabis dependence.
The purpose of the study will be to evaluate marijuana use patterns and tolerability of long-acting naltrexone in 7 treatment-seeking, cannabis-dependent outpatients; also to assess feasibility of conducting a larger trial with this medication. Cannabis dependent patients will have twice weekly clinic visits where they will receive injections of Vivitrol four weeks apart, in Week 1 and in Week 5. The psychosocial intervention for this study will be Medical Management, designed to facilitate adherence to the study medication and monitoring procedures, as well as to support the participant in achieving his or her marijuana use goals.
Participants will self-report cannabis use, will provide urine toxicology for quantitative assessment of THC (Tetrahydrocannabinol, the active ingredient in marijuana), and will provide serum samples for safety monitoring, and will answer questionnaires and will report on their physical and psychological health weekly.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long-acting injectable naltrexone | Experimental | Drug: Long-acting injectable naltrexoneTwo doses of long-acting injectable naltrexone, 380 mg by intramuscular injection in the gluteal muscle at study day 1 and again between study days 28-30. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between the ages of 18 - 60 years
- Meets DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, edition IV-TR) criteria for cannabis dependence
- Seeking treatment for cannabis dependence
- Reports using cannabis an average of 5 days per week over the past 28 days
- Capable of giving informed consent and complying with study procedures
Key exclusion criteria (11 listed)
- Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
- Currently meeting DSM-IV criteria for a psychiatric disorder that, according to the investigator's judgment, may require pharmacological or non-pharmacological intervention during the course of the study
- Receiving opioid analgesic medication
- Known history of allergy, intolerance, or hypersensitivity to naltrexone
- Pregnancy, lactation, or failure to use adequate contraceptive methods in female participants who are actively engaging in sexual activity with men
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 |
|---|---|---|
| Long-acting injectable naltrexoneAlso: VivitrolVivitrol is a long-acting opioid antagonist which blocks opioid agonists from binding at opioid receptors. It be administered as described above. | Drug | Long-acting injectable naltrexone |
Primary outcome
Change in Marijuana Use
Time frame: Weeks 1 - 8
Change in marijuana use, as measured by comparing the mean number of self reported days of marijuana use per week in the final study week, which will be week 8 or earlier if the participant discontinues as compared to the mean number of self reported days of marijuana use in week 1
Number of Participants Receiving the Second Injection of Study Medication
Time frame: Weeks 1 - 5
The number of participants who accept the second injection at week 5 will be used as one measure of tolerability.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 16223067Johnson BA, Ait-Daoud N, Roache JD. The COMBINE SAFTEE: a structured instrument for collecting adverse events adapted for clinical studies in the alcoholism field. J Stud Alcohol Suppl. 2005 Jul;(15):157-67; discussion 140. doi: 10.15288/jsas.2005.s15.157.
Related trials for Cannabis Dependence
Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
RecruitingObservational study
Cannabis Abstinence and Neurocognitive Assessment in Adolescence
Cannabis Dependence, Harmful Use
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Not yet recruitingEarly Phase 1
Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream
Cannabis Dependence
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.
Daniel P Notzon, M.D. principal investigator
Columbia and NY Psychiatric Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Long-acting injectable naltrexone in people with Cannabis 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 5 inclusion and 11 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 24 Apr 2019. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 18 Aug 2017). 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?
Change in Marijuana Use (time frame: Weeks 1 - 8). 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?
On the ClinicalTrials.gov record for NCT02088177, which also lists 1 linked publication.
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 24 Apr 2019.