Status:
COMPLETED
Pilot Trial of Bupropion Versus Placebo for Methamphetamine Abuse in Adolescents
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Behavioral Health Services, Inc.
Conditions:
Adolescent Methamphetamine Abuse
Eligibility:
All Genders
14-21 years
Phase:
PHASE2
Brief Summary
Dr Keith Heinzerling, who is a doctor at UCLA, is doing a research study with Behavioral Health Services in the Lincoln Heights neighborhood of Los Angeles to find out if a medication called bupropion...
Eligibility Criteria
Inclusion
- age 14 years to 21 years of age, inclusive;
- meet DSM-IV criteria for methamphetamine abuse or dependence as determined by the K-SADS-PL;
- seeking treatment for MA problems;
- report MA use on 18 or fewer of the past 30 days at baseline;
- willing and able to comply with study procedures;
- willing and able to provide informed assent (for youth \<18 yr) or consent (for youth ≥18 yr) and parents willing to provide informed consent (for youth \<18) to participate in the project; and
- able to complete study assessments in English due to the lack of some measures in Spanish;
- if female, not pregnant or lactating and willing to use an acceptable method of barrier birth control (e.g. condoms) during the trial.
Exclusion
- have a medical condition that, in the study physician's judgment, may interfere with safe study participation (e.g., active TB, unstable cardiac, renal, or liver disease, unstable diabetes);
- have a current neurological disorder (e.g., organic brain disease, dementia) or major psychiatric disorder not due to substance abuse (e.g., schizophrenia, bipolar disorder) as assessed by the K-SADS-PL other than attention deficit-hyperactivity disorder (see below) or a medical history which would make study agent compliance difficult or which would compromise informed consent, or history of suicide attempts in the past year and/or current serious suicidal intention or plan as assessed by the K-SADS-PL;
- currently taking bupropion for depression, smoking cessation or OCD within 30 days of baseline;
- taking any prescription medication for ADHD;
- currently on prescription medication that is contraindicated for use with bupropion;
- have current dependence on cocaine, opiates, alcohol, or benzodiazepines as defined by DSM-IV-TR;
- have a self-reported history of a seizure disorder or serious closed head injury;
- have a medical condition (such as serious head injury) that is associated with increased risk of seizures or on a medication that lowers the seizure threshold;
- have a current or past history of anorexia or bulimia;
- body weight less than 50kgs;
- have current hypertension uncontrolled by medication;
- have a history of sensitivity to bupropion; and
- any other circumstances that, in the opinion of the investigators, would compromise participant safety.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00994448
Start Date
October 1 2009
End Date
December 1 2011
Last Update
April 4 2013
Active Locations (1)
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1
Behavioral Health Services- Lincoln Heights Family Recovery Center
Los Angeles, California, United States, 90032