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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Behavioral Health Services, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupropion | Experimental |
| |
| Placebo (sugar pill) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupropion SR 150mg tabs | Drug | Bupropion SR 150mg tabs (Zyban) twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith Heinzerling, MD, MPH | UCLA Department of Family Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Behavioral Health Services- Lincoln Heights Family Recovery Center | Los Angeles | California | 90032 | United States |
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).
substance abuse clinic, community outreach
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupropion | Bupropion SR 150 mg twice a day |
| FG001 | Placebo (Sugar Pill) | Matching placebo tablets twice a day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupropion | Bupropion SR 150 mg twice a day |
| BG001 | Placebo (Sugar Pill) | Matching placebo tablets twice a day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | mean days retained in treatment for each grou[p](streamdown:incomplete-link) | Posted | Mean | Standard Deviation | days | 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bupropion | Bupropion SR 150 mg twice a day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders |
Study was not powered or designed to determine if bupropion is more effective than placebo for treating methamphetamine dependence. Only for pilot testing procedures for a clinical trial in methamphetamine abusing adolescents.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keith Heinzerling MD | UCLA | 310-794-0619 | KHeinzerling@mednet.ucla.edu |
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| ID | Term |
|---|---|
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
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| Placebo tablets |
| Drug |
One placebo tablet twice daily |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| 1 |
| 12 |
| 9 |
| 12 |
| EG001 | Placebo (Sugar Pill) | Matching placebo tablets twice a day | 0 | 7 | 4 | 7 |
| Flu symptoms | Infections and infestations |
|
| Upper Respiratory Infection | Infections and infestations |
|
| Blurry Vision | Eye disorders |
|
| Cold Sore | Infections and infestations |
|
| Diarrhea | Gastrointestinal disorders |
|
| Headache | Nervous system disorders |
|
| Meth cravings | Psychiatric disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Upset Stomach | Gastrointestinal disorders |
|
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