Feasibility and acceptability of a phase II randomized pharmacologic intervention for methamphetamine dependence in high-risk men who have sex with men.
OBJECTIVE
To determine whether actively using, methamphetamine (meth)-dependent men who have sex with men (msm) could be enrolled and retained in a pharmacologic intervention trial, and the degree to which participants would adhere to study procedures, including medication adherence. study design: phase ii randomized, double-blind trial of bupropion vs. placebo.


METHODS
Thirty meth-dependent, sexually active MSM were randomized to receive daily bupropion XL 300 mg or placebo for 12 weeks. Participants received weekly substance use counseling, provided weekly urine specimens, and completed monthly audio-computer assisted self-interview (ACASI) behavioral risk assessments. Adherence was measured by medication event monitoring systems (MEMS) caps (the number of distinct MEMS cap openings divided by the number of expected doses) and self-report.


RESULTS
Ninety percent completed the trial: 89% of monthly ACASIs were completed, 81% of study visits were attended, and 81% of urine samples were collected. Adherence by MEMS cap was 60% and by self-report was 81% and did not differ significantly by treatment assignment. The median number of positive urine samples was 5.5 out of a possible 11 (50%). Participants in both arms reported similar declines in the median number of sex partners (P = 0.52). No serious adverse events occurred and there were no significant differences in adverse events by treatment assignment (P = 0.11).


CONCLUSIONS
It is feasible to enroll and retain actively using, meth-dependent MSM in a pharmacologic intervention. Bupropion was well tolerated. Study participation and retention rates were high, however, study drug medication adherence was only moderate. Findings support a larger trial with improved adherence support to evaluate the efficacy of bupropion and other pharmacologic interventions for meth dependence in this population.
Das
Moupali
M
HIV Prevention Section, San Francisco Department of Public Health, CA 94102, USA. moupali.das-douglas@ucsf.edu
Santos
Deirdre
D
Matheson
Tim
T
Santos
Glenn-Milo
GM
Chu
Priscilla
P
Vittinghoff
Eric
E
Shoptaw
Steve
S
Colfax
Grant N
GN
D000293:Adolescent; D000328:Adult; D019969:Amphetamine-Related Disorders / Q000188:drug therapy* / Q000523:psychology; D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D016642:Bupropion / Q000627:therapeutic use*; D005240:Feasibility Studies; D018451:Homosexuality, Male; D006801:Humans; D008297:Male; D008694:Methamphetamine; D008875:Middle Aged; D018579:Patient Selection; D055815:Young Adult; D016903:Drug Monitoring
D018687:Antidepressive Agents, Second-Generation; D016642:Bupropion; D008694:Methamphetamine
Neuron. 2000 Mar;25(3):515-32
10774721
AIDS Care. 2003 Dec;15(6):775-85
14617499
AIDS Behav. 2004 Mar;8(1):87-98
15146136
J Pharmacol Exp Ther. 1999 Oct;291(1):409-15
10490931
Am J Psychiatry. 2001 Aug;158(8):1206-14
11481152
AIDS Behav. 2007 Mar;11(2):185-94
16897351
J Neurochem. 1993 May;60(5):1792-9
8473897
N Engl J Med. 2003 Sep 4;349(10):975-86
12954747
Sex Transm Dis. 2005 Jul;32(7):458-63
15976605
Drug Alcohol Depend. 2008 Aug 1;96(3):222-32
18468815
Am J Epidemiol. 2004 May 15;159(10):1002-12
15128613
Ann N Y Acad Sci. 2008 Oct;1141:195-220
18991959
Health Psychol. 2006 May;25(3):329-35
16719604
Addiction. 2001 Dec;96(12):1725-42
11784466
AIDS Care. 2009 May;21(5):575-82
19444665
Am J Public Health. 2003 Nov;93(11):1915-21
14600066
Am J Public Health. 2007 Jun;97(6):1067-75
17463384
J Urban Health. 2005 Mar;82(1 Suppl 1):i62-70
15738319
Gen Dent. 2006 Mar-Apr;54(2):125-9; quiz 130
16689071
J Subst Abuse Treat. 2005 Dec;29(4):295-306
16311182
Soc Sci Med. 1996 Mar;42(5):691-703
8685737
Nat Med. 1996 Jun;2(6):699-703
8640565
Am J Public Health. 2001 Jun;91(6):953-8
11392940
Ann Intern Med. 2001 May 15;134(10):968-77
11352698
Proc Natl Acad Sci U S A. 1988 Jul;85(14):5274-8
2899326
J Addict Dis. 2002;21(1):107-19
11831496
Addiction. 2004 Jun;99(6):708-17
15139869
Neuron. 1996 May;16(5):893-6
8630244
J Stud Alcohol. 1999 Nov;60(6):837-45
10606497
Biol Psychiatry. 2009 Apr 15;65(8):706-9
19136097
Addict Sci Clin Pract. 2008 Jun;4(2):28-35
18497715
J Acquir Immune Defic Syndr. 2007 May 1;45(1):85-92
17325605
Addiction. 2001 Nov;96(11):1589-601
11784456
Arch Surg. 2004 Aug;139(8):844-7
15302693
Biol Psychiatry. 2001 Jan 15;49(2):81-96
11164755
Am J Public Health. 1999 Jun;89(6):825-33
10358670
J Subst Abuse Treat. 2005 Sep;29(2):85-93
16135337
AIDS. 2004 Jan 1;18 Suppl 1:S19-25
15075494
J Neurosci. 2009 Feb 11;29(6):1887-96
19211895
Drug Alcohol Depend. 2005 May 9;78(2):125-34
15845315
J Neuropsychiatry Clin Neurosci. 2003 Summer;15(3):317-25
12928507
Nat Rev Neurosci. 2001 Feb;2(2):119-28
11252991
Sex Transm Infect. 2006 Apr;82(2):131-4
16581738
J Addict Dis. 2006;25(4):105-14
17088230
Neuropsychopharmacology. 2008 Apr;33(5):1162-70
17581531
J Psychoactive Drugs. 2000 Apr-Jun;32(2):221-8
10908011
AIDS. 2007 Jan 11;21(2):239-41
17197817
Am J Public Health. 2003 Jun;93(6):933-8
12773358
MMWR Morb Mortal Wkly Rep. 1995 Dec 1;44(47):882-6
7476843
N Engl J Med. 1988 May 5;318(18):1173-82
3283549
J Neurosci. 2002 May 1;22(9):3312-20
11978805
J Psychoactive Drugs. 2003 May;35 Suppl 1:161-8
12825759
AIDS. 2000 Mar 10;14(4):357-66
10770537
J Med Internet Res. 2004 Nov 29;6(4):e41
15631965
Science. 1997 Oct 3;278(5335):52-8
9311926
Curr Opin Psychiatry. 2005 May;18(3):235-42
16639146
Am J Epidemiol. 2000 Jul 15;152(2):99-106
10909945
Oral Health Prev Dent. 2005;3(3):189-95
16355653
AIDS Care. 2004 Nov;16(8):1036-47
15511735
Am J Public Health. 2009 Apr;99 Suppl 1:S157-64
18445808
Br J Psychiatry. 2003 Feb;182:97-100
12562734
J Neurosci. 1998 Oct 15;18(20):8417-22
9763484
J Tenn Dent Assoc. 2006 Fall;86(4):32-5
17228534
Neuropharmacology. 2005 Nov;49(6):820-30
16005476
J Psychoactive Drugs. 2000 Apr-Jun;32(2):211-20
10908010
Pharmacol Biochem Behav. 1997 Jul;57(3):513-21
9218276
Harv Rev Psychiatry. 2005 May-Jun;13(3):141-54
16020027
Am J Addict. 2000 Summer;9(3):222-31
11000918
Arch Intern Med. 1996 Nov 11;156(20):2287-93
8911235
J Subst Abuse Treat. 2002 Sep;23(2):145-50
12220612