Improving Substance Use and Clinical Outcomes in Heavy Cannabis Users With Quetiapine (CD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Feinstein Institute for Medical Research.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Feinstein Institute for Medical Research
ClinicalTrials.gov Identifier:
NCT01153490
First received: June 28, 2010
Last updated: May 27, 2011
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Cannabis Dependence
Behavioral: Behavioral Intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Substance Use and Clinical Outcomes in Heavy Cannabis Users With Quetiapine

Resource links provided by NLM:


Further study details as provided by Feinstein Institute for Medical Research:

Primary Outcome Measures:
  • Frequency/amount of substance use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    frequency and amount of cannabis and other substance use will be recorded with the Timeline Follow-Back Method.

  • Psychotic symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Psychotic symptoms wil be assessed with the Structured Interview for Prodromal Symptoms and the Brief Psychiatric Rating Scale.


Secondary Outcome Measures:
  • Craving [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Craving will be assessed with the Marijuana Craving Questionnaire and a Visual Analog Craving Scale

  • Mood symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Mood symptoms will be assessed with the Hamilton Depression Rating Scale

  • Adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 120
Study Start Date: July 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Behavioral: Behavioral Intervention
Substance-related
Active Comparator: Quetiapine ER Behavioral: Behavioral Intervention
Substance-related

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153490

Contacts
Contact: Christina E Ryan, B.A. 718-470-4255 cryan3@nshs.edu
Contact: Serge Sevy, M.D., MBA 718-470-8175 sevy@lij.edu

Locations
United States, New York
The Zucker Hillside Hospital Recruiting
Glen Oaks, New York, United States, 11004
Contact: Christina E Ryan, B.A.    718-470-4255    cryan3@nshs.edu   
Principal Investigator: Serge Sevy, M.D., MBA         
General Clinical Research Center Recruiting
Manhasset, New York, United States, 11030
Contact: Christina E Ryan, B.A.    718-470-4255    cryan3@nshs.edu   
Principal Investigator: Serge Sevy, M.D., MBA         
Sponsors and Collaborators
Feinstein Institute for Medical Research
Investigators
Principal Investigator: Serge Sevy, M.D., MBA Feinstein Institute for Medical Research
  More Information

No publications provided

Responsible Party: Serge Sevy, MD, Feinstein Institute for Medical Research
ClinicalTrials.gov Identifier: NCT01153490     History of Changes
Other Study ID Numbers: 10-159B
Study First Received: June 28, 2010
Last Updated: May 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Feinstein Institute for Medical Research:
Quetiapine
Psychotic experiences
Cannabis dependence
Craving
Mood
Substance use

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 21, 2014