Trial Outcomes & Findings for Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM) (NCT NCT00285584)
NCT ID: NCT00285584
Last Updated: 2017-12-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
41 participants
Primary outcome timeframe
Enrollment to Month 6
Results posted on
2017-12-12
Participant Flow
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.
Participant milestones
| Measure |
Bupropion
Participants in this arm received bupropion.
|
Placebo
Participants in this arm received placebo.
|
|---|---|---|
|
Enrollment (Month 0)
STARTED
|
20
|
21
|
|
Enrollment (Month 0)
COMPLETED
|
20
|
21
|
|
Enrollment (Month 0)
NOT COMPLETED
|
0
|
0
|
|
Month 3
STARTED
|
20
|
21
|
|
Month 3
COMPLETED
|
16
|
18
|
|
Month 3
NOT COMPLETED
|
4
|
3
|
|
Month 6
STARTED
|
16
|
18
|
|
Month 6
COMPLETED
|
16
|
17
|
|
Month 6
NOT COMPLETED
|
0
|
1
|
|
Month 9
STARTED
|
16
|
17
|
|
Month 9
COMPLETED
|
15
|
14
|
|
Month 9
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Bupropion
Participants in this arm received bupropion.
|
Placebo
Participants in this arm received placebo.
|
|---|---|---|
|
Month 3
Lost to Follow-up
|
3
|
3
|
|
Month 3
Withdrawal by Subject
|
1
|
0
|
|
Month 6
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM)
Baseline characteristics by cohort
| Measure |
Bupropion
n=20 Participants
Participants in this arm received bupropion.
|
Placebo
n=21 Participants
Participants in this arm received placebo.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.5 years
n=5 Participants
|
32 years
n=7 Participants
|
32 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Enrollment to Month 6Population: Subjects remaining in study through 6-Month study visit.
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.
Outcome measures
| Measure |
Bupropion
n=16 Participants
6 months
|
Placebo
n=17 Participants
6 months
|
|---|---|---|
|
The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment.
|
-2.5 Sexual partners
Interval -50.0 to 0.0
|
-4 Sexual partners
Interval -10.0 to 4.0
|
SECONDARY outcome
Timeframe: Month 6 compared to Month 0 (enrollment)Population: All subjects who were randomized, met study inclusion/exclusion criteria and were followed through Month 6
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.
Outcome measures
| Measure |
Bupropion
n=16 Participants
6 months
|
Placebo
n=17 Participants
6 months
|
|---|---|---|
|
Change in the Frequency Per Month of Use of Recreational Drugs Between Enrollment and Month 6 Measured by Questionnaire.
|
0.5 Drug-using occasions per month
Interval -7.5 to 23.0
|
0 Drug-using occasions per month
Interval -15.0 to 15.0
|
SECONDARY outcome
Timeframe: Enrollment to Month 6Population: Self-reported and laboratory identified sexually transmitted infections
Number of participants with incident sexually transmitted disease between enrollment the Month 6 interview.
Outcome measures
| Measure |
Bupropion
n=20 Participants
6 months
|
Placebo
n=21 Participants
6 months
|
|---|---|---|
|
Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing)
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Month 6 compared to enrollment (Month 0)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
Outcome measures
| Measure |
Bupropion
n=16 Participants
6 months
|
Placebo
n=17 Participants
6 months
|
|---|---|---|
|
Change in Beck Depression Inventory - II (BDI-II) Scores Between Enrollment and Month 6.
|
-11.5 units on a scale
Interval -31.0 to 8.0
|
-9 units on a scale
Interval -19.0 to 5.0
|
Adverse Events
Bupropion
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bupropion
n=20 participants at risk
Participants in this arm received bupropion.
|
Placebo
n=21 participants at risk
Participants in this arm received placebo.
|
|---|---|---|
|
Infections and infestations
Hospitalization with acute HIV infection
|
5.0%
1/20 • Number of events 1 • From enrollment through the 9-month follow-up.
|
0.00%
0/21 • From enrollment through the 9-month follow-up.
|
|
General disorders
Hospitalization with left-sided chest pain radiating the left arm
|
5.0%
1/20 • Number of events 1 • From enrollment through the 9-month follow-up.
|
0.00%
0/21 • From enrollment through the 9-month follow-up.
|
Other adverse events
| Measure |
Bupropion
n=20 participants at risk
Participants in this arm received bupropion.
|
Placebo
n=21 participants at risk
Participants in this arm received placebo.
|
|---|---|---|
|
Cardiac disorders
Elevated diastolic pressure (>= 80 mm Hg) at Months 3, 6 or 9
|
62.5%
10/16 • Number of events 16 • From enrollment through the 9-month follow-up.
|
42.9%
6/14 • Number of events 10 • From enrollment through the 9-month follow-up.
|
|
Cardiac disorders
Elevated systolic pressure (>= 140 mm Hg) at Months 3, 6 or 9
|
12.5%
2/16 • Number of events 2 • From enrollment through the 9-month follow-up.
|
17.6%
3/17 • Number of events 4 • From enrollment through the 9-month follow-up.
|
|
General disorders
Weight loss
|
0.00%
0/20 • From enrollment through the 9-month follow-up.
|
9.5%
2/21 • Number of events 2 • From enrollment through the 9-month follow-up.
|
|
General disorders
Dry mouth
|
25.0%
5/20 • Number of events 8 • From enrollment through the 9-month follow-up.
|
19.0%
4/21 • Number of events 4 • From enrollment through the 9-month follow-up.
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
4/20 • Number of events 6 • From enrollment through the 9-month follow-up.
|
23.8%
5/21 • Number of events 8 • From enrollment through the 9-month follow-up.
|
|
Nervous system disorders
Insomnia
|
35.0%
7/20 • Number of events 11 • From enrollment through the 9-month follow-up.
|
0.00%
0/21 • From enrollment through the 9-month follow-up.
|
|
Nervous system disorders
Headache
|
30.0%
6/20 • Number of events 10 • From enrollment through the 9-month follow-up.
|
19.0%
4/21 • Number of events 6 • From enrollment through the 9-month follow-up.
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 1 • From enrollment through the 9-month follow-up.
|
9.5%
2/21 • Number of events 4 • From enrollment through the 9-month follow-up.
|
|
Nervous system disorders
Agitation
|
10.0%
2/20 • Number of events 2 • From enrollment through the 9-month follow-up.
|
4.8%
1/21 • Number of events 1 • From enrollment through the 9-month follow-up.
|
|
Nervous system disorders
Somnolence
|
5.0%
1/20 • Number of events 1 • From enrollment through the 9-month follow-up.
|
9.5%
2/21 • Number of events 2 • From enrollment through the 9-month follow-up.
|
|
Nervous system disorders
Fatigue
|
25.0%
5/20 • Number of events 5 • From enrollment through the 9-month follow-up.
|
9.5%
2/21 • Number of events 2 • From enrollment through the 9-month follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
30.0%
6/20 • Number of events 8 • From enrollment through the 9-month follow-up.
|
23.8%
5/21 • Number of events 11 • From enrollment through the 9-month follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus problem
|
15.0%
3/20 • Number of events 4 • From enrollment through the 9-month follow-up.
|
9.5%
2/21 • Number of events 2 • From enrollment through the 9-month follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • Number of events 2 • From enrollment through the 9-month follow-up.
|
9.5%
2/21 • Number of events 2 • From enrollment through the 9-month follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
2/20 • Number of events 2 • From enrollment through the 9-month follow-up.
|
9.5%
2/21 • Number of events 2 • From enrollment through the 9-month follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.0%
3/20 • Number of events 7 • From enrollment through the 9-month follow-up.
|
4.8%
1/21 • Number of events 1 • From enrollment through the 9-month follow-up.
|
|
Skin and subcutaneous tissue disorders
Excessive sweating
|
0.00%
0/20 • From enrollment through the 9-month follow-up.
|
9.5%
2/21 • Number of events 3 • From enrollment through the 9-month follow-up.
|
|
Infections and infestations
Fever
|
5.0%
1/20 • Number of events 1 • From enrollment through the 9-month follow-up.
|
9.5%
2/21 • Number of events 2 • From enrollment through the 9-month follow-up.
|
|
Infections and infestations
Chlamydia trachomatis infection
|
10.0%
2/20 • Number of events 2 • From enrollment through the 9-month follow-up.
|
4.8%
1/21 • Number of events 1 • From enrollment through the 9-month follow-up.
|
|
Infections and infestations
Streptococcal infection of throat
|
10.0%
2/20 • Number of events 2 • From enrollment through the 9-month follow-up.
|
0.00%
0/21 • From enrollment through the 9-month follow-up.
|
|
Infections and infestations
Upper respiratory infection
|
30.0%
6/20 • Number of events 6 • From enrollment through the 9-month follow-up.
|
42.9%
9/21 • Number of events 13 • From enrollment through the 9-month follow-up.
|
|
Infections and infestations
Eye infection
|
15.0%
3/20 • Number of events 3 • From enrollment through the 9-month follow-up.
|
9.5%
2/21 • Number of events 2 • From enrollment through the 9-month follow-up.
|
|
Cardiac disorders
Heart palpitations
|
10.0%
2/20 • Number of events 3 • From enrollment through the 9-month follow-up.
|
0.00%
0/21 • From enrollment through the 9-month follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
2/20 • Number of events 4 • From enrollment through the 9-month follow-up.
|
19.0%
4/21 • Number of events 5 • From enrollment through the 9-month follow-up.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
2/20 • Number of events 2 • From enrollment through the 9-month follow-up.
|
0.00%
0/21 • From enrollment through the 9-month follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60