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Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM)

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ClinicalTrials.gov Identifier: NCT00285584
Recruitment Status : Completed
First Posted : February 2, 2006
Results First Posted : June 20, 2012
Last Update Posted : December 12, 2017
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
GlaxoSmithKline
Information provided by (Responsible Party):
New York University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions HIV Infections
Depression
Interventions Drug: Bupropion
Drug: Placebo
Enrollment 41
Recruitment Details Recruitment: Sept. 2002 - March 2004. High-risk, HIV-seronegative, New York City men who have sex with men (MSM) were informed of the study by field workers at MSM-oriented bars, clubs and community events; advertisements in magazines distributed at such venues; and e-mails to persons offering sexual services for MSM on the Internet.
Pre-assignment Details  
Arm/Group Title Bupropion Placebo
Hide Arm/Group Description Participants in this arm received bupropion. Participants in this arm received placebo.
Period Title: Enrollment (Month 0)
Started 20 21
Completed 20 21
Not Completed 0 0
Period Title: Month 3
Started 20 21
Completed 16 18
Not Completed 4 3
Reason Not Completed
Lost to Follow-up             3             3
Withdrawal by Subject             1             0
Period Title: Month 6
Started 16 18
Completed 16 17
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Period Title: Month 9
Started 16 17
Completed 15 14
Not Completed 1 3
Arm/Group Title Bupropion Placebo Total
Hide Arm/Group Description Participants in this arm received bupropion. Participants in this arm received placebo. Total of all reporting groups
Overall Number of Baseline Participants 20 21 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants 21 participants 41 participants
32.5
(23 to 48)
32
(20 to 48)
32
(20 to 48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 41 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
20
 100.0%
21
 100.0%
41
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 41 participants
Hispanic or Latino
2
  10.0%
5
  23.8%
7
  17.1%
Not Hispanic or Latino
18
  90.0%
16
  76.2%
34
  82.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 41 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  10.0%
1
   4.8%
3
   7.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  30.0%
4
  19.0%
10
  24.4%
White
10
  50.0%
16
  76.2%
26
  63.4%
More than one race
2
  10.0%
0
   0.0%
2
   4.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 21 participants 41 participants
20 21 41
1.Primary Outcome
Title The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment.
Hide Description The self-reported number of partners in unprotected anal intercourse during the 3 months prior to interview as reported at the Month 6 visit minus reported at the enrollment visit.
Time Frame Enrollment to Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects remaining in study through 6-Month study visit.
Arm/Group Title Bupropion Placebo
Hide Arm/Group Description:
6 months
6 months
Overall Number of Participants Analyzed 16 17
Median (Full Range)
Unit of Measure: Sexual partners
-2.5
(-50 to 0)
-4
(-10 to 4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupropion, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 1.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in the Frequency Per Month of Use of Recreational Drugs Between Enrollment and Month 6 Measured by Questionnaire.
Hide Description Within-individual changes in the frequency of use of recreational drugs per month in the 3 months prior to interview reported at the Month 6 visit minus that reported at the enrollment visit.
Time Frame Month 6 compared to Month 0 (enrollment)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who were randomized, met study inclusion/exclusion criteria and were followed through Month 6
Arm/Group Title Bupropion Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 16 17
Median (Full Range)
Unit of Measure: Drug-using occasions per month
0.5
(-7.5 to 23)
0
(-15 to 15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupropion, Placebo
Comments Wilcoxon rank test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 0.5
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing)
Hide Description Number of participants with incident sexually transmitted disease between enrollment the Month 6 interview.
Time Frame Enrollment to Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Self-reported and laboratory identified sexually transmitted infections
Arm/Group Title Bupropion Placebo
Hide Arm/Group Description:
Participants in this arm received bupropion.
Participants in this arm received placebo.
Overall Number of Participants Analyzed 20 21
Measure Type: Number
Unit of Measure: participants
3 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupropion, Placebo
Comments Comparison of cumulative incidence proportions
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 3.15
Confidence Interval (2-Sided) 95%
0.4 to 27.8
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Beck Depression Inventory - II (BDI-II) Scores Between Enrollment and Month 6.
Hide Description The BDI-II is a self-administered, multiple-choice questionnaire inquiring into the presence and severity of symptoms associated with depression. BDI-II scores range from 0 to 63, with 10-19 interpreted as mild-to-moderate; 20-29 as moderate-to-severe, and ≥ 30 as severe depression. The study outcome measure was the BDI-II score at Month 6 minus the BDI score at enrollment
Time Frame Month 6 compared to enrollment (Month 0)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupropion Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 16 17
Median (Full Range)
Unit of Measure: units on a scale
-11.5
(-31 to 8)
-9
(-19 to 5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupropion, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -2.5
Estimation Comments [Not Specified]
Time Frame From enrollment through the 9-month follow-up.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bupropion Placebo
Hide Arm/Group Description Participants in this arm received bupropion. Participants in this arm received placebo.
All-Cause Mortality
Bupropion Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bupropion Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      0/21 (0.00%)    
General disorders     
Hospitalization with left-sided chest pain radiating the left arm * [1]  1/20 (5.00%)  1 0/21 (0.00%)  0
Infections and infestations     
Hospitalization with acute HIV infection * [1]  1/20 (5.00%)  1 0/21 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Note that both SAEs occurred in a single individual enrolled in the bupropion arm of the study.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bupropion Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/20 (90.00%)      18/21 (85.71%)    
Cardiac disorders     
Elevated diastolic pressure (>= 80 mm Hg) at Months 3, 6 or 9   10/16 (62.50%)  16 6/14 (42.86%)  10
Elevated systolic pressure (>= 140 mm Hg) at Months 3, 6 or 9   2/16 (12.50%)  2 3/17 (17.65%)  4
Heart palpitations   2/20 (10.00%)  3 0/21 (0.00%)  0
Gastrointestinal disorders     
Diarrhea   4/20 (20.00%)  6 5/21 (23.81%)  8
General disorders     
Weight loss   0/20 (0.00%)  0 2/21 (9.52%)  2
Dry mouth   5/20 (25.00%)  8 4/21 (19.05%)  4
Infections and infestations     
Fever *  1/20 (5.00%)  1 2/21 (9.52%)  2
Chlamydia trachomatis infection   2/20 (10.00%)  2 1/21 (4.76%)  1
Streptococcal infection of throat   2/20 (10.00%)  2 0/21 (0.00%)  0
Upper respiratory infection   6/20 (30.00%)  6 9/21 (42.86%)  13
Eye infection   3/20 (15.00%)  3 2/21 (9.52%)  2
Musculoskeletal and connective tissue disorders     
Back pain   2/20 (10.00%)  4 4/21 (19.05%)  5
Myalgia   2/20 (10.00%)  2 0/21 (0.00%)  0
Nervous system disorders     
Insomnia   7/20 (35.00%)  11 0/21 (0.00%)  0
Headache   6/20 (30.00%)  10 4/21 (19.05%)  6
Dizziness   1/20 (5.00%)  1 2/21 (9.52%)  4
Agitation   2/20 (10.00%)  2 1/21 (4.76%)  1
Somnolence   1/20 (5.00%)  1 2/21 (9.52%)  2
Fatigue   5/20 (25.00%)  5 2/21 (9.52%)  2
Respiratory, thoracic and mediastinal disorders     
Pharyngitis   6/20 (30.00%)  8 5/21 (23.81%)  11
Sinus problem   3/20 (15.00%)  4 2/21 (9.52%)  2
Cough   2/20 (10.00%)  2 2/21 (9.52%)  2
Nasal congestion   2/20 (10.00%)  2 2/21 (9.52%)  2
Skin and subcutaneous tissue disorders     
Rash   3/20 (15.00%)  7 1/21 (4.76%)  1
Excessive sweating   0/20 (0.00%)  0 2/21 (9.52%)  3
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
We achieved substantially lower recruitment than needed to adequately test the study hypothesis. We also experienced substantial losses-to-follow-up.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Results Point of Contact
Name/Title: Michael Marmor, Ph.D.
Organization: NYU School of Medicine
Phone: 212-263-6667
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00285584     History of Changes
Other Study ID Numbers: NIDA-15303-1
R01DA015303 ( U.S. NIH Grant/Contract )
DPMC
First Submitted: January 31, 2006
First Posted: February 2, 2006
Results First Submitted: March 13, 2012
Results First Posted: June 20, 2012
Last Update Posted: December 12, 2017