Cocaine-Related DisordersPhase 2NCT00015210
Nefazodone in the Treatment of Cocaine Dependence and Depression - 4
A Phase 2 study testing Nefazodone and Psychosocial Treatment in people with Cocaine-Related Disorders and Substance-Related Disorders, run by Boston Medical Center at 1 site in United States.
Trial summary
The purpose of this study is the use of Nefazodone in the treatment of cocaine dependence and depression comorbidity. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Cocaine-Related Disorders, Substance-Related Disorders
- What is being tested?
- Nefazodone and Psychosocial Treatment
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1997to May 1999
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-IV diagnosis of cocaine dependence, Depression score of 12 or above and history of depression. Males and non-pregnant, non-nursing females 21-55 years of age.
Who cannot join
- Axis I diagnosis other than substance use disorder, major depression, anxiety of dysthymic disorder. Physiological dependence on alcohol. Significant medical or neurological history. Abnormal UA, CBC or Chem 23 (LFT's may be up to 3 times normal). Enrollment in an opiate-substitution treatment program within 45 days of enrollment in the present study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Nefazodone in Cocaine Dependent Subjects
The purpose of this study is the use of Nefazodone in the treatment of cocaine dependence and depression comorbidity.
Read the detailed description
The objective of this study is to determine the safety and efficacy of nefazodone (Serzone ) in depressed cocaine dependent subjects. This is a hypothesis-testing study which will explore whether cocaine usage will be reduced in the nefazodone treatment group compared to a placebo control group.
- Being tested
- Nefazodone, Psychosocial Treatment
- Keywords
- Cocaine Use Disorders Dependence Depression
- Medical subject headings
- Cocaine-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NefazodoneDrug
Also called Serzone
Psychosocial TreatmentBehavioural
Also called Indivdual Manual-quided relapse prevention therapy, or Individual Dug Counseling
All subjects attended a weekly 1-hour therapy session during the 8 week treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Nefazodone | Active comparator | Nefazodone 100 mg tablet, titrated to a maximum of 200 mg administered twice daily by treatment day 10. Drug tapered over 7 days at the conclusion of the treatment period. Treatment was administered for 8 weeks. Receives: Drug: Nefazodone; Behavioral: Psychosocial Treatment |
| Matched Placebo Tablet | Placebo comparator | Matched placebo tablet, titrated up to 2 tablets twice daily by day 10 and tapered over 7 days at the conclusion of the study. Treatment period lasted 8 weeks. Receives: Drug: Nefazodone; Behavioral: Psychosocial Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine benzoylecgonine (BE) concentration
Natural log BE in urine samples collected weekly were analyzed for the baseline week and the subsequent 8 treatment weeks.
Measured: Study Weeks Basekine to Week 8
Secondary outcomes (4)
Hamilton Depression Scale (HAM-D)
HAM-D collected on a weekly basis.
Measured: Baseline through Study Week 8
Cocaine-Craving Scale
CCS scores were collected on a weekly basis.
Measured: Baseline through Week 8
Adverse Events Self Report
Data for adverse events were collected on a weekly basis
Measured: Study Weeks 1 through 8
Alcohol Drug Use Inventory
Subjects were asked about the amount of cocaine consumed and the number of days in cocaine was used in the previous week, on a weekly basis.
Measured: Baseline through Study Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2001 (estimated)
- Study startFeb 1997
- Primary completionMay 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cocaine-Related DisordersStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University
- Responsible party
- Principal investigator, Dominic Ciraulo, Boston Medical Center
- Investigators
- Dom Ciraulo, M.D., Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00015210
- Sponsor's protocol ID
- NIDA-5-0013-4
- Other IDs
- Y01-5-0013-4
- Status last verified
- Jul 2015
- First submitted
- 18 Apr 2001
- Last updated
- 30 Jul 2015
- Results posted
- No
Publications
Ciraulo DA, Knapp C, Rotrosen J, Sarid-Segal O, Ciraulo AM, LoCastro J, Greenblatt DJ, Leiderman D. Nefazodone treatment of cocaine dependence with comorbid depressive symptoms. Addiction. 2005 Mar;100 Suppl 1:23-31. doi: 10.1111/j.1360-0443.2005.00984.x.
PubMed 15730347
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nefazodone in Cocaine Dependent Subjects
- ClinicalTrials.gov ID
- NCT00015210
- Acronym / sponsor ID
- NIDA-5-0013-4
- Keywords
- Cocaine Use Disorders Dependence Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Boston University
- Study start
- Feb 1997
- Primary completion
- May 1999 (actual)
- First posted
- 18 Apr 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is the use of Nefazodone in the treatment of cocaine dependence and depression comorbidity.
Detailed description
The objective of this study is to determine the safety and efficacy of nefazodone (Serzone ) in depressed cocaine dependent subjects. This is a hypothesis-testing study which will explore whether cocaine usage will be reduced in the nefazodone treatment group compared to a placebo control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nefazodone | Active comparator | Drug: Nefazodone, Behavioral: Psychosocial TreatmentNefazodone 100 mg tablet, titrated to a maximum of 200 mg administered twice daily by treatment day 10. Drug tapered over 7 days at the conclusion of the treatment period. Treatment was administered for 8 weeks. |
| Matched Placebo Tablet | Placebo comparator | Drug: Nefazodone, Behavioral: Psychosocial TreatmentMatched placebo tablet, titrated up to 2 tablets twice daily by day 10 and tapered over 7 days at the conclusion of the study. Treatment period lasted 8 weeks. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- DSM-IV diagnosis of cocaine dependence, Depression score of 12 or above and history of depression. Males and non-pregnant, non-nursing females 21-55 years of age.
Key exclusion criteria (1 listed)
- Axis I diagnosis other than substance use disorder, major depression, anxiety of dysthymic disorder. Physiological dependence on alcohol. Significant medical or neurological history. Abnormal UA, CBC or Chem 23 (LFT's may be up to 3 times normal). Enrollment in an opiate-substitution treatment program within 45 days of enrollment in the present study.
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 |
|---|---|---|
| NefazodoneAlso: Serzone | Drug | Matched Placebo Tablet, Nefazodone |
| Psychosocial TreatmentAlso: Indivdual Manual-quided relapse prevention therapy, or Individual Dug CounselingAll subjects attended a weekly 1-hour therapy session during the 8 week treatment period. | Behavioural | Matched Placebo Tablet, Nefazodone |
Primary outcome
Urine benzoylecgonine (BE) concentration
Time frame: Study Weeks Basekine to Week 8
Natural log BE in urine samples collected weekly were analyzed for the baseline week and the subsequent 8 treatment weeks.
4 secondary outcomes
Hamilton Depression Scale (HAM-D)
Time frame: Baseline through Study Week 8
Cocaine-Craving Scale
Time frame: Baseline through Week 8
Adverse Events Self Report
Time frame: Study Weeks 1 through 8
Alcohol Drug Use Inventory
Time frame: Baseline through Study Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
- Background: PubMed 15730347Ciraulo DA, Knapp C, Rotrosen J, Sarid-Segal O, Ciraulo AM, LoCastro J, Greenblatt DJ, Leiderman D. Nefazodone treatment of cocaine dependence with comorbid depressive symptoms. Addiction. 2005 Mar;100 Suppl 1:23-31. doi: 10.1111/j.1360-0443.2005.00984.x.
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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.
Dom Ciraulo, M.D. principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nefazodone and Psychosocial Treatment in people with Cocaine-Related Disorders and Substance-Related Disorders, run by Boston Medical Center at 1 site 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 1 inclusion and 1 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 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Urine benzoylecgonine (BE) concentration (time frame: Study Weeks Basekine to Week 8). 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 NCT00015210, which also lists 1 linked publication.
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 30 Jul 2015.