Effectiveness of Buspirone and Motivational Enhancement Therapy for the Treatment of Marijuana Dependence - 1

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00149617
First received: September 6, 2005
Last updated: September 11, 2012
Last verified: December 2007
  Purpose

This study will assess the effectiveness of a combination of buspirone and motivational interviewing therapy in the treatment of marijuana dependence.


Condition Intervention Phase
Marijuana Abuse
Mood Disorders
Drug: Buspirone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Career Training in Marijuana Dependence

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Drug use; measured at Weeks 12 and 16

Secondary Outcome Measures:
  • Anxiety; measured at Week 12
  • Craving; measured at Week 12
  • Withdrawal symptoms; measured at Week 12

Enrollment: 81
Study Start Date: April 2004
Study Completion Date: December 2007
Detailed Description:

Marijuana dependence is one of the most common substance-related disorders in the United States. Despite its prevalence, there is a lack of clinical research addressing treatments for marijuana dependence. Research has shown that marijuana abuse is associated with affective disorders. This may be caused by repeated use for relief from anxiety. The use of an anxiolytic agent, a drug that relieves anxiety, may help treat marijuana dependence. Motivational enhancement therapy has been shown to reduce marijuana use. Therefore, it is likely that buspirone, which is an anxiolytic agent, combined with motivational enhancement therapy will prove beneficial in treating marijuana dependence. This study will assess the effectiveness of a combination of buspirone and motivational interviewing in the treatment of marijuana dependence.

This double-blind study will last a total of 16 weeks. Participants will be randomly assigned to receive either buspirone or placebo for a period of 12 weeks. There will be one follow-up appointment 4 weeks post-intervention. Baseline assessments will include a physical exam and urine and blood tests. Study visits will occur weekly throughout treatment in order to monitor compliance, assess adverse affects, and obtain substance use data. Mood assessment scales, marijuana craving questionnaires, and a withdrawal symptom checklist will be used to gather the data. Urine drug screens will be collected weekly to test for marijuana use. In addition to this, the presence of opioids, cocaine, amphetamines, and benzodiazepines will be tested at baseline, Weeks 6 and 12, and at follow-up. A 10-day supply of medication will be dispensed to participants each week. Meetings for motivational enhancement therapy will last 30 to 90 minutes each and will occur at baseline, Week 2, and Week 4. Participants' perceived quality of life will be measured at baseline and Weeks 6 and 12 to determine the effect of buspirone.

  Eligibility

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

Inclusion Criteria:

  • Meets DSM-IV criteria for marijuana dependence
  • Lives within 60 miles of the study site
  • Willing to provide collateral individuals for contact purposes
  • Willing to use an effective form of contraception throughout the study

Exclusion Criteria:

  • Meets DSM-IV criteria for dependence upon a substance other than marijuana, nicotine, or caffeine
  • Meets DSM-IV criteria for a history of schizophrenia or another non-affective psychotic disorder or bipolar disorder
  • Meets DSM-IV criteria for current major depressive disorder or eating disorder
  • Significant cognitive impairment
  • Currently taking benzodiazepines, antidepressant, or antipsychotic medications
  • Major medical illnesses (e.g., HIV, kidney failure, unstable angina, chronic obstructive pulmonary disease, infectious hepatitis)
  • Not in stable housing
  • Pregnant or breastfeeding
  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: NCT00149617

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Aimee Mcrae, Pharm.D. Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Aimee L. McRae, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00149617     History of Changes
Other Study ID Numbers: NIDA-15440-1, K23DA015440, K23-15440-1, DPMC
Study First Received: September 6, 2005
Last Updated: September 11, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Mood Disorders
Marijuana Abuse
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Buspirone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014