Status:
COMPLETED
Improving Substance Use and Clinical Outcomes in Heavy Cannabis Users With Quetiapine
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cannabis Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 with...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- 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
Key Trial Info
Start Date :
October 22 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2012
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT01153490
Start Date
October 22 2010
End Date
August 6 2012
Last Update
April 17 2018
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
2
General Clinical Research Center
Manhasset, New York, United States, 11030