Pilot Trial of Bupropion Versus Placebo for Methamphetamine Abuse in Adolescents

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT00994448
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH), Behavioral Health Services, Inc. (Industry)
• Enrollment: 19
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adolescent Methamphetamine Abuse	Drug: Bupropion SR 150mg tabs; Drug: Placebo tablets	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pilot Trial of Bupropion Versus Placebo for Methamphetamine Abuse in Adolescents
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bupropion	Drug: Bupropion SR 150mg tabs; Bupropion SR 150mg tabs (Zyban) twice daily
Placebo Comparator: Placebo (sugar pill)	Drug: Placebo tablets; One placebo tablet twice daily

Outcome Measures

Primary Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 21 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Behavioral Health Services- Lincoln Heights Family Recovery Center	Los Angeles	California	United States	90032

Sponsors and Collaborators

• University of California, Los Angeles
• National Institute on Drug Abuse (NIDA)
• Behavioral Health Services, Inc.

Investigators

• Principal Investigator: Keith Heinzerling, MD, MPH, UCLA Department of Family Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Keith Heinzerling, Assistant Clinical Professor, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT00994448
• Other Study ID Numbers: 1R21DA026513
• First Posted: Oct 14, 2009
• Last Update Posted: Apr 4, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by Keith Heinzerling, Assistant Clinical Professor, University of California, Los Angeles: Adolescents; Methamphetamine abuse; Bupropion; Addiction; Pharmacotherapy; Cognitive Behavioral Therapy; Contingency Management; Teens
• Additional relevant MeSH terms: Bupropion

Study Results

Participant Flow

Recruitment Details	substance abuse clinic, community outreach
Pre-assignment Detail	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).

Arm/Group Title	Bupropion	Placebo (Sugar Pill)
Arm/Group Description	Bupropion SR 150 mg twice a day	Matching placebo tablets twice a day
Period Title: Overall Study
STARTED	12	7
COMPLETED	4	5
NOT COMPLETED	8	2

Baseline Characteristics

Arm/Group Title	Bupropion	Placebo (Sugar Pill)	Total
Arm/Group Description	Bupropion SR 150 mg twice a day	Matching placebo tablets twice a day	Total of all reporting groups
Overall Participants	12	7	19
Age (Count of Participants)
<=18 years	7 58.3%	4 57.1%	11 57.9%
Between 18 and 65 years	5 41.7%	3 42.9%	8 42.1%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	17.5 (1.6)	17.7 (1.1)	17.5 (1.4)
Sex: Female, Male (Count of Participants)
Female	7 58.3%	3 42.9%	10 52.6%
Male	5 41.7%	4 57.1%	9 47.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	11 91.7%	6 85.7%	17 89.5%
Not Hispanic or Latino	1 8.3%	1 14.3%	2 10.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	1 14.3%	1 5.3%
Black or African American	0 0%	0 0%	0 0%
White	12 100%	6 85.7%	18 94.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	12 100%	7 100%	19 100%

Outcome Measures

1. Primary Outcome

Title	Feasibility of Retaining Adolescents in Trial
Description	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

Outcome Measure Data

Analysis Population Description

mean days retained in treatment for each grou[p

Arm/Group Title	Bupropion	Placebo (Sugar Pill)
Arm/Group Description	Bupropion SR 150 mg twice a day	Matching placebo tablets twice a day
Measure Participants	12	7
Mean (Standard Deviation) [days]	33.3 (21.2)	49.3 (9.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bupropion, Placebo (Sugar Pill)
	Comments	t test for mean of days retained in the bupropion versus placebo groups
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.08
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	16.3
	Confidence Interval	(2-Sided) 95%; 1.8 to 34.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 8.6
	Estimation Comments

Adverse Events

Arm/Group Title	Bupropion		Placebo (Sugar Pill)
Arm/Group Description	Bupropion SR 150 mg twice a day		Matching placebo tablets twice a day
All Cause Mortality
	Bupropion		Placebo (Sugar Pill)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Bupropion		Placebo (Sugar Pill)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)		0/7 (0%)
Psychiatric disorders
Suicidal ideation	1/12 (8.3%)	1	0/7 (0%)	0
Other (Not Including Serious) Adverse Events
	Bupropion		Placebo (Sugar Pill)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/12 (75%)		4/7 (57.1%)
Eye disorders
Blurry Vision	0/12 (0%)	0	1/7 (14.3%)	1
Gastrointestinal disorders
Abdominal Pain	1/12 (8.3%)	1	1/7 (14.3%)	1
Diarrhea	1/12 (8.3%)	1	0/7 (0%)	0
Nausea	1/12 (8.3%)	1	0/7 (0%)	0
Upset Stomach	1/12 (8.3%)	1	0/7 (0%)	0
Infections and infestations
Flu symptoms	2/12 (16.7%)	2	0/7 (0%)	0
Upper Respiratory Infection	1/12 (8.3%)	1	1/7 (14.3%)	1
Cold Sore	1/12 (8.3%)	1	0/7 (0%)	0
Nervous system disorders
Headache	1/12 (8.3%)	1	0/7 (0%)	0
Psychiatric disorders
Meth cravings	0/12 (0%)	0	1/7 (14.3%)	1

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.