HIV InfectionsPhase 1NCT00285584
Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM)
A Phase 1 study testing Bupropion in people with HIV Infections and Depression, run by NYU Langone Health at 2 sites in United States.
Trial summary
The primary purpose of this study was to test the whether high-risk, HIV-seronegative persons with mild-to-moderate depression would be more likely to adopt protective behavior change when provided with pharmacotherapy for their depression than when treated with placebo. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV Infections, Depression
- What is being tested?
- Bupropion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2002to Sep 2004
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Available for at least 9 months, or the duration of the study
- Willing to complete HIV testing and counseling
- History of HIV testing and counseling
- At high risk of HIV infection, indicated by more than one male sexual partner in the 3 months prior to study entry
- Meets criteria for either (a) major depression or dysthymia within a mild-to-moderate level according to standard criteria DSM-IV, or (b) minor depression as defined by one or more of the following symptoms at any time and for any duration during the past 12 months: significant weight loss or gain, or significant decrease or increase in appetite; poor sleep pattern; noticeable irritability or slowness; fatigue or lack of energy; inappropriate feelings of worthlessness or guilt; inability to concentrate; indecisiveness; and recurrent thoughts of death or suicide.
Who cannot join
- HIV infected
- Sexual intercourse in the 3 months prior to study entry with only one partner, and in a monogamous relationship
- Currently enrolled in another study involving repeated HIV testing and counseling
- Receiving treatment for depression with antidepressant medication for any length of time within the year prior to study entry
- Currently in psychotherapy, psychoanalysis, or any other form of talk therapy for any reason
- Severe depression or at suicidal risk
Show all 11Show fewer
- No evidence or prior history of depression
- Homicidal or other similar problem that, in the opinion of the investigator, may endanger study staff and participants
- Currently taking monoamine oxidase inhibitors (MAOIs). Participants may be allowed to enroll 14 days after discontinuing use of a MAOI.
- History of seizures
- History or current symptoms of bipolar disorder
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bellevue Hospital Center
New York, New York, 10016-3240
New York University School of Medicine
New York, New York, 10016-3240
About this study
Official title: Drug Abuse, Depression and Responses to HIV Counseling
The primary purpose of this study was to test the whether high-risk, HIV-seronegative persons with mild-to-moderate depression would be more likely to adopt protective behavior change when provided with pharmacotherapy for their depression than when treated with placebo. High-risk behaviors include using illegal drugs and participating in unprotected sexual intercourse. The specific pharmacotherapy used in this study was the anti-depressant, bupropion. The subject population consisted of HIV negative men who have sex with men (MSM) with mild-to-moderate depression.
Read the detailed description
Depression in men is often masked by high-risk behaviors such as alcohol and drug abuse. Common symptoms among depressed men include feelings of hopelessness and helplessness, irritability, and anger. MSM are among those at highest for HIV acquisition due to high-risk behaviors, including unprotected sexual intercourse and drug abuse. Bupropion is an antidepressant medication commonly used to treat depression. The purpose of this study thus was whether bupropion could help MSM with mild-to-moderate depression reduce their high-risk behaviors.
Participants in this trial were randomly assigned to receive either bupropion or placebo for 6 months. Study visits lasting approximately 2 hours each occurred at Day 0, and at Months 4, 6, and 9; included in these visits were physical examination, testing for HIV and sexually transmitted disease (STD), depression screening, and an interview-administered questionnaire inquiring into sexual activity and drug use. Shorter study visits, lasting 15 - 30 minutes each occurred at Day 15, and Months 1, 2, 4, 5, and 7, and included depression screening and physical exam.
- Conditions
- HIV Infections, Depression
- Being tested
- Bupropion, Placebo
- Keywords
- HIV infection, Depression, Men who have sex with men, Drug abuse
- Medical subject headings
- HIV Infections, Depression, Homosexuality, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
Also called Brand name of bupropion used in the trial: Wellbutrin SR
Participants initially received bupropion, 150 mg, once daily, to be taken in the morning. Dosage was increased to 150 mg twice daily within one month. Return visits were conducted monthly from study Months 1 through 6 to review medication dosage, ascertain side effects and evaluate depression severity. At the end of Moth 6, subjects were tapered to 150 mg/day over a period of 4 - 7 days. The final 150 mg/day dosage of bupropion allowed referral for pharmacotherapy without unblinding subjects or staff regarding bupropion/placebo assignment. Subjects were followed through Month 9 to permit evaluation of the durability of intervention effects.
PlaceboDrug
Participants initially received placebo, 150 mg, once daily, to be taken in the morning. Dosage was increased to 150 mg twice daily within one month. Return visits were conducted monthly from study Months 1 through 6 to review medication dosage, ascertain side effects and evaluate depression severity. At the end of Moth 6, subjects were tapered to 150 mg/day over a period of 4 - 7 days. The final 150 mg/day dosage allowed referral for pharmacotherapy without unblinding subjects or staff regarding bupropion/placebo assignment. Subjects were followed through Month 9 to permit evaluation of the durability of intervention effects.
| Study group | Role | What they receive |
|---|---|---|
| Bupropion | Active comparator | Participants in this arm received bupropion. Receives: Drug: Bupropion |
| Placebo | Placebo comparator | Participants in this arm received placebo that looked identical to the active comparator medication. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment.
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.
Measured: Enrollment to Month 6
Secondary outcomes (3)
Change in the Frequency Per Month of Use of Recreational Drugs Between Enrollment and Month 6 Measured by Questionnaire.
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.
Measured: Month 6 compared to Month 0 (enrollment)
Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing)
Number of participants with incident sexually transmitted disease between enrollment the Month 6 interview.
Measured: Enrollment to Month 6
Change in Beck Depression Inventory - II (BDI-II) Scores Between Enrollment and Month 6.
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
Measured: Month 6 compared to enrollment (Month 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startSep 2002
- Primary completionMar 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Michael Marmor, PhD, Principal investigator, Department of Environmental Medicine, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285584
- Sponsor's protocol ID
- NIDA-15303-1
- Other IDs
- R01DA015303, DPMC
- Status last verified
- Nov 2017
- First submitted
- 31 Jan 2006
- Last updated
- 12 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Thomas SM, Tse DB, Ketner DS, Rochford G, Meyer DA, Zade DD, Halkitis PN, Nadas A, Borkowsky W, Marmor M. CCR5 expression and duration of high risk sexual activity among HIV-seronegative men who have sex with men. AIDS. 2006 Sep 11;20(14):1879-83. doi: 10.1097/01.aids.0000244207.49123.ff.
PubMed 16954729Marmor M, Hertzmark K, Thomas SM, Halkitis PN, Vogler M. Resistance to HIV infection. J Urban Health. 2006 Jan;83(1):5-17. doi: 10.1007/s11524-005-9003-8.
PubMed 16736351Halkitis PN, Zade DD, Shrem M, Marmor M. Beliefs about HIV non-infection and risky sexual behavior among MSM. AIDS Educ Prev. 2004 Oct;16(5):448-58. doi: 10.1521/aeap.16.5.448.48739.
PubMed 15491956Marmor M, Penn A, Widmer K, Levin RI, Maslansky R. Coronary artery disease and opioid use. Am J Cardiol. 2004 May 15;93(10):1295-7. doi: 10.1016/j.amjcard.2004.01.072.
PubMed 15135709
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Abuse, Depression and Responses to HIV Counseling
- ClinicalTrials.gov ID
- NCT00285584
- Acronym / sponsor ID
- NIDA-15303-1
- Conditions
- HIV Infections, Depression
- Keywords
- HIV infection, Depression, Men who have sex with men, Drug abuse
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), GlaxoSmithKline
- Study start
- Sep 2002
- Primary completion
- Mar 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 2 Feb 2006 (estimated)
- Results
- Posted 20 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study was to test the whether high-risk, HIV-seronegative persons with mild-to-moderate depression would be more likely to adopt protective behavior change when provided with pharmacotherapy for their depression than when treated with placebo. High-risk behaviors include using illegal drugs and participating in unprotected sexual intercourse. The specific pharmacotherapy used in this study was the anti-depressant, bupropion. The subject population consisted of HIV negative men who have sex with men (MSM) with mild-to-moderate depression.
Detailed description
Depression in men is often masked by high-risk behaviors such as alcohol and drug abuse. Common symptoms among depressed men include feelings of hopelessness and helplessness, irritability, and anger. MSM are among those at highest for HIV acquisition due to high-risk behaviors, including unprotected sexual intercourse and drug abuse. Bupropion is an antidepressant medication commonly used to treat depression. The purpose of this study thus was whether bupropion could help MSM with mild-to-moderate depression reduce their high-risk behaviors.
Participants in this trial were randomly assigned to receive either bupropion or placebo for 6 months. Study visits lasting approximately 2 hours each occurred at Day 0, and at Months 4, 6, and 9; included in these visits were physical examination, testing for HIV and sexually transmitted disease (STD), depression screening, and an interview-administered questionnaire inquiring into sexual activity and drug use. Shorter study visits, lasting 15 - 30 minutes each occurred at Day 15, and Months 1, 2, 4, 5, and 7, and included depression screening and physical exam.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupropion | Active comparator | Drug: BupropionParticipants in this arm received bupropion. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants in this arm received placebo that looked identical to the active comparator medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Available for at least 9 months, or the duration of the study
- Willing to complete HIV testing and counseling
- History of HIV testing and counseling
- At high risk of HIV infection, indicated by more than one male sexual partner in the 3 months prior to study entry
- Meets criteria for either (a) major depression or dysthymia within a mild-to-moderate level according to standard criteria DSM-IV, or (b) minor depression as defined by one or more of the following symptoms at any time and for any duration during the past 12 months: significant weight loss or gain, or significant decrease or increase in appetite; poor sleep pattern; noticeable irritability or slowness; fatigue or lack of energy; inappropriate feelings of worthlessness or guilt; inability to concentrate; indecisiveness; and recurrent thoughts of death or suicide.
Key exclusion criteria (11 listed)
- HIV infected
- Sexual intercourse in the 3 months prior to study entry with only one partner, and in a monogamous relationship
- Currently enrolled in another study involving repeated HIV testing and counseling
- Receiving treatment for depression with antidepressant medication for any length of time within the year prior to study entry
- Currently in psychotherapy, psychoanalysis, or any other form of talk therapy for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupropionAlso: Brand name of bupropion used in the trial: Wellbutrin SRParticipants initially received bupropion, 150 mg, once daily, to be taken in the morning. Dosage was increased to 150 mg twice daily within one month. Return visits were conducted monthly from study Months 1 through 6 to review medication dosage, ascertain side effects and evaluate depression severity. At the end of Moth 6, subjects were tapered to 150 mg/day over a period of 4 - 7 days. The final 150 mg/day dosage of bupropion allowed referral for pharmacotherapy without unblinding subjects or staff regarding bupropion/placebo assignment. Subjects were followed through Month 9 to permit evaluation of the durability of intervention effects. | Drug | Bupropion |
| PlaceboParticipants initially received placebo, 150 mg, once daily, to be taken in the morning. Dosage was increased to 150 mg twice daily within one month. Return visits were conducted monthly from study Months 1 through 6 to review medication dosage, ascertain side effects and evaluate depression severity. At the end of Moth 6, subjects were tapered to 150 mg/day over a period of 4 - 7 days. The final 150 mg/day dosage allowed referral for pharmacotherapy without unblinding subjects or staff regarding bupropion/placebo assignment. Subjects were followed through Month 9 to permit evaluation of the durability of intervention effects. | Drug | Placebo |
Primary outcome
The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment.
Time frame: Enrollment to Month 6
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.
3 secondary outcomes
Change in the Frequency Per Month of Use of Recreational Drugs Between Enrollment and Month 6 Measured by Questionnaire.
Time frame: Month 6 compared to Month 0 (enrollment)
Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing)
Time frame: Enrollment to Month 6
Change in Beck Depression Inventory - II (BDI-II) Scores Between Enrollment and Month 6.
Time frame: Month 6 compared to enrollment (Month 0)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16954729Thomas SM, Tse DB, Ketner DS, Rochford G, Meyer DA, Zade DD, Halkitis PN, Nadas A, Borkowsky W, Marmor M. CCR5 expression and duration of high risk sexual activity among HIV-seronegative men who have sex with men. AIDS. 2006 Sep 11;20(14):1879-83. doi: 10.1097/01.aids.0000244207.49123.ff.
- Background: PubMed 16736351Marmor M, Hertzmark K, Thomas SM, Halkitis PN, Vogler M. Resistance to HIV infection. J Urban Health. 2006 Jan;83(1):5-17. doi: 10.1007/s11524-005-9003-8.
- Background: PubMed 15491956Halkitis PN, Zade DD, Shrem M, Marmor M. Beliefs about HIV non-infection and risky sexual behavior among MSM. AIDS Educ Prev. 2004 Oct;16(5):448-58. doi: 10.1521/aeap.16.5.448.48739.
- Background: PubMed 15135709Marmor M, Penn A, Widmer K, Levin RI, Maslansky R. Coronary artery disease and opioid use. Am J Cardiol. 2004 May 15;93(10):1295-7. doi: 10.1016/j.amjcard.2004.01.072.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Marmor, PhD principal investigator
Department of Environmental Medicine, New York University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bupropion in people with HIV Infections and Depression, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment. (time frame: Enrollment to Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00285584, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2017.