Adolescent Methamphetamine Abuse
Conditions
Keywords
Adolescents, Methamphetamine abuse, Bupropion, Addiction, Pharmacotherapy, Cognitive Behavioral Therapy, Contingency Management, Teens
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 can help adolescents (age 14-21) reduce or stop using methamphetamine. Bupropion is a drug that is already on the market, which means it has been approved by the FDA, but it has not been approved to treat methamphetamine abuse. What the study is trying to find out is if bupropion helps people to stop using methamphetamine. The study lasts up to 14 weeks and involves visits to the BHS clinic in Lincoln Heights twice a week. The first two weeks involve completion of questionnaires and assessments, including a physical exam, a blood test, EKG (a test that checks for problems with the electrical activity of a person's heart), and a psychological interview, to see if you are eligible for the study. If you are eligible, then you will be assigned by chance to take either the bupropion pills or placebo pills, which are pills that look the same, but contain no medication. This type of study is called a double blind study because neither you nor any of the study staff will know which medication you are taking. During the 8 weeks of taking the pills, you'll visit the clinic to complete additional questionnaires and assessments, to provide urine samples for testing for methamphetamine, and for once a week drug abuse counseling. At the end of your treatment, you'll have another physical exam including blood tests and the same test on your heart and then we'll ask you to come to the clinic once a week for four weeks for follow-up assessments. You'll be compensated for time spent doing research activities and for returning empty medication packages. The total compensation possible is $332 in gift cards for places such as Target, iTunes, groceries, and gas. Your participation in the study is voluntary and deciding not to participate or deciding to stop participating at any time during the study is okay.
Interventions
DRUGBupropion SR 150mg tabs
Bupropion SR 150mg tabs (Zyban) twice daily
DRUGPlacebo tablets
One placebo tablet twice daily
Sponsors
National Institute on Drug Abuse (NIDA)
Behavioral Health Services, Inc.
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
1. age 14 years to 21 years of age, inclusive; 2. meet DSM-IV criteria for methamphetamine abuse or dependence as determined by the K-SADS-PL; 3. seeking treatment for MA problems; 4. report MA use on 18 or fewer of the past 30 days at baseline; 5. willing and able to comply with study procedures; 6. 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 7. able to complete study assessments in English due to the lack of some measures in Spanish; 8. if female, not pregnant or lactating and willing to use an acceptable method of barrier birth control (e.g. condoms) during the trial.
Exclusion criteria
1. 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); 2. 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; 3. currently taking bupropion for depression, smoking cessation or OCD within 30 days of baseline; 4. taking any prescription medication for ADHD; 5. currently on prescription medication that is contraindicated for use with bupropion; 6. have current dependence on cocaine, opiates, alcohol, or benzodiazepines as defined by DSM-IV-TR; 7. have a self-reported history of a seizure disorder or serious closed head injury; 8. 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; 9. have a current or past history of anorexia or bulimia; 10. body weight less than 50kgs; 11. have current hypertension uncontrolled by medication; 12. have a history of sensitivity to bupropion; and 13. any other circumstances that, in the opinion of the investigators, would compromise participant safety.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Retaining Adolescents in Trial | 8 weeks | the mean retention for participants is used to assess feasibility of retaining adolescents in the trial (completion = 56 days or 8 weeks) |
Countries
United States
Participant flow
Recruitment details
substance abuse clinic, community outreach
Pre-assignment details
Reasons for not being randomized were: withdrew voluntarily (4), failed to complete assessments (2), psychiatric disorder (2), weight \< 50 kg (2), alcohol dependent (1), and incarcerated (1).
Participants by arm
| Arm | Count |
|---|---|
| Bupropion Bupropion SR 150 mg twice a day | 12 |
| Placebo (Sugar Pill) Matching placebo tablets twice a day | 7 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 5 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Bupropion | Placebo (Sugar Pill) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 7 Participants | 4 Participants | 11 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 3 Participants | 8 Participants |
| Age Continuous | 17.5 years STANDARD_DEVIATION 1.6 | 17.7 years STANDARD_DEVIATION 1.1 | 17.5 years STANDARD_DEVIATION 1.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 6 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 6 Participants | 18 Participants |
| Region of Enrollment United States | 12 participants | 7 participants | 19 participants |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 10 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 12 | 4 / 7 |
| serious Total, serious adverse events | 1 / 12 | 0 / 7 |
Outcome results
Primary
Feasibility of Retaining Adolescents in Trial
the mean retention for participants is used to assess feasibility of retaining adolescents in the trial (completion = 56 days or 8 weeks)
Time frame: 8 weeks
Population: mean days retained in treatment for each grou\[p
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupropion | Feasibility of Retaining Adolescents in Trial | 33.3 days | Standard Deviation 21.2 |
| Placebo (Sugar Pill) | Feasibility of Retaining Adolescents in Trial | 49.3 days | Standard Deviation 9.8 |
Comparison: t test for mean of days retained in the bupropion versus placebo groupsp-value: 0.0895% CI: [1.8, 34.3]t-test, 2 sided