Cannabis DependencePhase 4CDNCT01153490
Improving Substance Use and Clinical Outcomes in Heavy Cannabis Users With Quetiapine
A Phase 4 study testing Behavioral Intervention in people with Cannabis Dependence, run by Northwell Health at 2 sites in United States.
Trial summary
Cannabis is the most used illicit substance in the United States. Previous studies suggest that atypical antipsychotics decrease the frequency and the amount of substance use in subjects with and without psychotic illness. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cannabis Dependence
- What is being tested?
- Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Oct 2010to 6 Aug 2012
- Phase
- Phase 4
- 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
- DSM-IV-defined diagnosis of cannabis dependence (304.30) assessed with the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P) (First 1998))
- one or more attenuated positive symptoms with a score 3 ('moderate'), 4 ('moderate severe'), or 5 ('severe but not psychotic') during the past year assessed with the Structured Interview for Prodromal Syndromes (SIPS) and the Scale of Prodromal Symptoms (SOPS) (McGlashan et al, 2001)
- lifetime treatment with antipsychotic medication less than 2 weeks
- cannabis use for more than one year
- cannabis use three or more days per week on average for the past 3 months
- aged 18 to 65
- competent and willing to sign informed consent
- for women, a negative urine pregnancy test and agreement to use a medically accepted method of birth control during the study.
Who cannot join
- DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, a psychotic disorder due to a general medical condition, psychosis NOS, delusional disorder, brief psychotic disorder, shared psychotic disorder, or a mood disorder (major depression or bipolar) with psychotic features assessed with the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P) (First 1998)
- DSM-IV diagnosis of any psychoactive substance dependence other than cannabis or nicotine
- being in an environment with no access to cannabis (e.g., hospitalization, residential treatment, jail, ..) for more than one week during the past three months preceding study entry
- serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain
- use of medications that have an effect on monoamines (e.g., antidepressants
- severe medical or physical illnesses
Show all 16Show fewer
- criteria of the National Cholesterol Education Program (NCEP) for a metabolic syndrome (Expert panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, 2001)
- medical condition that requires treatment with a medication that has psychotropic effects
- significant risk of suicidal or homicidal behavior
- cognitive or language limitations, or any other factor that would preclude subjects providing informed consent or participating in study procedures
- treatment with medications for addiction
- treatment with medication having a risk of addiction (e.g., benzodiazepines, barbiturates)
- history of treatment resistance to quetiapine ER
- medical contraindications to quetiapine ER
- hypersensitivity to quetiapine ER or any of its component
- for women, pregnant, breastfeeding, or intention to become pregnant during the study timeframe
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Zucker Hillside Hospital
Glen Oaks, New York, 11004
General Clinical Research Center
Manhasset, New York, 11030
About this study
Cannabis is the most used illicit substance in the United States. Previous studies suggest that atypical antipsychotics decrease the frequency and the amount of substance use in subjects with and without psychotic illness. So far, there are no controlled studies assessing the effectiveness of atypical antipsychotics for decreasing cannabis and other substance use in individuals with cannabis use disorders. The investigators postulate that the atypical antipsychotic quetiapine ER is an effective agent for improving substance use outcomes in subjects with cannabis use disorders. In this pilot study, the investigators will test this hypothesis in heavy cannabis users (i.e., individuals who are cannabis dependent and smoke three times or more per week). Because 50% of these heavy cannabis users report histories of psychotic experiences (i.e., attenuated positive symptoms) while smoking and are at risk for recurring psychotic symptoms, the investigators will focus this pilot clinical trial on this subgroup of cannabis users in order to increase the risk/benefit ratio of this study and target a population that may also benefit from the antipsychotic effect of quetiapine ER. Considering the lack of controlled studies assessing the efficacy of atypical antipsychotics in heavy cannabis users, assessing the effectiveness of an atypical antipsychotic medication on substance use and clinical outcomes in this population is critical for improving the prognosis of these individuals.
Thus, the aims of this randomized, double-blind, placebo-controlled study are to assess the efficacy of an atypical antipsychotic (quetiapine ER) in 120 subjects with cannabis dependence, a recent history (within a year) of attenuated psychotic symptoms, and using cannabis 3 times or more per week for: (1) decreasing the use of cannabis and other substances; and (2) preventing the recurrence of psychotic experiences. The investigators will also assess the effects of quetiapine ER on craving and mood, and its tolerability. This project will be a 12-week, randomized, double-blind, placebo-controlled study with quetiapine ER and it will include a comprehensive assessment of symptoms, substance use, and side effects.
This study will benefit the field by providing unique data on the relative efficacy and tolerability of treatment with atypical antipsychotics in heavy cannabis users with a vulnerability to psychosis. This study will be the basis for future studies assessing the long-term efficacy and tolerability of atypical antipsychotics in individuals with cannabis use disorders.
- Conditions
- Cannabis Dependence
- Being tested
- Behavioral Intervention
- Keywords
- Quetiapine, Psychotic experiences, Cannabis dependence, Craving, Mood, Substance use
- Medical subject headings
- Marijuana Abuse, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Substance-related
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Behavioral: Behavioral Intervention |
| Quetiapine ER | Active comparator | Not described Receives: Behavioral: Behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency/amount of substance use
frequency and amount of cannabis and other substance use will be recorded with the Timeline Follow-Back Method.
Measured: 12 weeks
Psychotic symptoms
Psychotic symptoms wil be assessed with the Structured Interview for Prodromal Symptoms and the Brief Psychiatric Rating Scale.
Measured: 12 weeks
Secondary outcomes (3)
Craving
Craving will be assessed with the Marijuana Craving Questionnaire and a Visual Analog Craving Scale
Measured: 12 weeks
Mood symptoms
Mood symptoms will be assessed with the Hamilton Depression Rating Scale
Measured: 12 weeks
Adverse events
Adverse events will be assessed with the Systematic Assessment for Treatment Emergent Events interview, Simpson-Angus Scale for Extrapyramidal Symptoms, the Abnormal Involuntary Movement Scale, the Barnes Akathisia Scale, and blood tests (fasting glucose, insulin and lipid profile tests)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study start22 Oct 2010
- Primary completion6 Aug 2012
- Study completion6 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis DependenceStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Raphael Braga, Northwell Health
- Investigators
- Serge Sevy, M.D., MBA, Principal investigator, Feinstein Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153490
- Sponsor's protocol ID
- 10-159B
- Acronym
- CD
- Status last verified
- Apr 2018
- First submitted
- 28 Jun 2010
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Substance Use and Clinical Outcomes in Heavy Cannabis Users With Quetiapine
- ClinicalTrials.gov ID
- NCT01153490
- Acronym / sponsor ID
- CD / 10-159B
- Conditions
- Cannabis Dependence
- Keywords
- Quetiapine, Psychotic experiences, Cannabis dependence, Craving, Mood, Substance use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 22 Oct 2010 (actual)
- Primary completion
- 6 Aug 2012 (actual)
- Study completion
- 6 Aug 2012 (actual)
- First posted
- 30 Jun 2010 (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.
Cannabis is the most used illicit substance in the United States. Previous studies suggest that atypical antipsychotics decrease the frequency and the amount of substance use in subjects with and without psychotic illness. So far, there are no controlled studies assessing the effectiveness of atypical antipsychotics for decreasing cannabis and other substance use in individuals with cannabis use disorders. The investigators postulate that the atypical antipsychotic quetiapine ER is an effective agent for improving substance use outcomes in subjects with cannabis use disorders. In this pilot study, the investigators will test this hypothesis in heavy cannabis users (i.e., individuals who are cannabis dependent and smoke three times or more per week). Because 50% of these heavy cannabis users report histories of psychotic experiences (i.e., attenuated positive symptoms) while smoking and are at risk for recurring psychotic symptoms, the investigators will focus this pilot clinical trial on this subgroup of cannabis users in order to increase the risk/benefit ratio of this study and target a population that may also benefit from the antipsychotic effect of quetiapine ER. Considering the lack of controlled studies assessing the efficacy of atypical antipsychotics in heavy cannabis users, assessing the effectiveness of an atypical antipsychotic medication on substance use and clinical outcomes in this population is critical for improving the prognosis of these individuals.
Thus, the aims of this randomized, double-blind, placebo-controlled study are to assess the efficacy of an atypical antipsychotic (quetiapine ER) in 120 subjects with cannabis dependence, a recent history (within a year) of attenuated psychotic symptoms, and using cannabis 3 times or more per week for: (1) decreasing the use of cannabis and other substances; and (2) preventing the recurrence of psychotic experiences. The investigators will also assess the effects of quetiapine ER on craving and mood, and its tolerability. This project will be a 12-week, randomized, double-blind, placebo-controlled study with quetiapine ER and it will include a comprehensive assessment of symptoms, substance use, and side effects.
This study will benefit the field by providing unique data on the relative efficacy and tolerability of treatment with atypical antipsychotics in heavy cannabis users with a vulnerability to psychosis. This study will be the basis for future studies assessing the long-term efficacy and tolerability of atypical antipsychotics in individuals with cannabis use disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Behavioral: Behavioral Intervention |
| Quetiapine ER | Active comparator | Behavioral: Behavioral Intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- DSM-IV-defined diagnosis of cannabis dependence (304.30) assessed with the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P) (First 1998))
- one or more attenuated positive symptoms with a score 3 ('moderate'), 4 ('moderate severe'), or 5 ('severe but not psychotic') during the past year assessed with the Structured Interview for Prodromal Syndromes (SIPS) and the Scale of Prodromal Symptoms (SOPS) (McGlashan et al, 2001)
- lifetime treatment with antipsychotic medication less than 2 weeks
- cannabis use for more than one year
- cannabis use three or more days per week on average for the past 3 months
Key exclusion criteria (16 listed)
- DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, a psychotic disorder due to a general medical condition, psychosis NOS, delusional disorder, brief psychotic disorder, shared psychotic disorder, or a mood disorder (major depression or bipolar) with psychotic features assessed with the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P) (First 1998)
- DSM-IV diagnosis of any psychoactive substance dependence other than cannabis or nicotine
- being in an environment with no access to cannabis (e.g., hospitalization, residential treatment, jail, ..) for more than one week during the past three months preceding study entry
- serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain
- use of medications that have an effect on monoamines (e.g., antidepressants
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 |
|---|---|---|
| Behavioral InterventionSubstance-related | Behavioural | Placebo, Quetiapine ER |
Primary outcome
Frequency/amount of substance use
Time frame: 12 weeks
frequency and amount of cannabis and other substance use will be recorded with the Timeline Follow-Back Method.
Psychotic symptoms
Time frame: 12 weeks
Psychotic symptoms wil be assessed with the Structured Interview for Prodromal Symptoms and the Brief Psychiatric Rating Scale.
3 secondary outcomes
Craving
Time frame: 12 weeks
Mood symptoms
Time frame: 12 weeks
Adverse events
Time frame: 12 weeks
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 17 Apr 2018.
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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.
Serge Sevy, M.D., MBA principal investigator
Feinstein Institute for Medical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Behavioral Intervention in people with Cannabis Dependence, run by Northwell Health 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 8 inclusion and 16 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 17 Apr 2018. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Frequency/amount of substance use (time frame: 12 weeks). 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 17 Apr 2018.