Cocaine-Related DisordersPhase 2NCT00000271
New Approaches to Cocaine Abuse Medications (A) - 6
A Phase 2 study testing Desipramine in people with Cocaine-Related Disorders and Substance-Related Disorders, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The purpose of this study is to measure the effect of desipramine in cocaine abusers selected for major depression or dysthymia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cocaine-Related Disorders, Substance-Related Disorders
- What is being tested?
- Desipramine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1995to Oct 2002
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meets DSM-IV criteria for current cocaine dependence.
- Used cocaine at least one day in the past month.
- Currently meets DSM-IV criteria for Major Depression or Dysthymia.
- Depressive disorder is either:
- primary (antedates earliest lifetime substance abuse or
- persistent during 6 months of abstinence in the past or
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- at least 3 months duration in the current episode
- Age 18-60.
- Able to give informed consent and comply with study procedures.
Who cannot join
- Meets DSM-IV criteria for past mania (i.e. bipolar disorder), schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse.
- History of seizures.
- History of allergic reaction to desipramine or imipramine.
- Chronic organic mental disorder.
- Significant current suicidal risk.
- Pregnancy, lactation or failure in sexually active female patients to use adequate contraceptive methods.
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- Unstable physical disorders which might make participation hazardous such as hypertension, hepatitis or diabetes.
- Coronary vascular disease as indicated by history or suspected by abnormal ECG or history or cardiac symptoms.
- Cardiac conduction system disease as indicated by QRS duration >0.11.
- Current use of other prescribed psychotropic medications within the last 2 weeks.
- History of failure to respond to a previous adequate trial of desipramine or another tricyclic antidepressant.
- Currently meets criteria for another substance dependence disorder (DSM-IV) other than nicotine, marijuana or alcohol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Research Foundation for Mental Hygiene
New York, New York, 10032
About this study
Official title: New Approaches to Cocaine Abuse Medications (A)
The purpose of this study is to measure the effect of desipramine in cocaine abusers selected for major depression or dysthymia.
Read the detailed description
This is a randomized, 12-week, double-blind, 'placebo-controlled trial of outpatients meeting DSM-III-R criteria for cocaine dependence and major depression or dysthymia (by SCID interview). Participants were treated with desipramine, up to 300 mg per day, or matching placebo. All patients received weekly individual manual-guided relapse prevention therapy. Weekly outcome measures included the Clinical Global Impression Scale, self-reported cocaine use and craving, urine toxicology, and the Hamilton Depression Scale.
- Being tested
- Desipramine, Placebo
- Keywords
- Desipramine, cocaine, depression
- Medical subject headings
- Cocaine-Related Disorders, Substance-Related Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesipramineDrug
Also called desmethylimipramine
Participants were treated with desipramine, up to 300 mg per day, or matching placebo. All participants received weekly individual manual-guided relapse prevention therapy.
PlaceboDrug
Participants were treated with matching placebo. All participants received weekly individual manual-guided relapse prevention therapy.
| Study group | Role | What they receive |
|---|---|---|
| Desipramine | Experimental | Participants were treated with desipramine, up to 300 mg per day. All patients received weekly individual manual-guided relapse prevention therapy. Receives: Drug: Desipramine |
| Placebo | Placebo comparator | Participants were treated with matching placebo. All patients received weekly individual manual-guided relapse prevention therapy. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine Use
Clinical Global Impression Scale, self-reported cocaine use and craving, urine toxicology.
Measured: Weekly over a 12 week period.
Depression
Hamilton Depression Scale
Measured: Bi-weekly over a 12 week period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 1999 (estimated)
- Study startJan 1995
- Primary completionOct 2002
- Study completionOct 2002
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.
- 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
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Herbert Kleber, M.D., Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000271
- Sponsor's protocol ID
- 3881
- Other IDs
- 5P50DA009236-18
- Status last verified
- Jun 2017
- First submitted
- 20 Sep 1999
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McDowell D, Nunes EV, Seracini AM, Rothenberg J, Vosburg SK, Ma GJ, Petkova E. Desipramine treatment of cocaine-dependent patients with depression: a placebo-controlled trial. Drug Alcohol Depend. 2005 Nov 1;80(2):209-21. doi: 10.1016/j.drugalcdep.2005.03.026.
PubMed 15913920
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Approaches to Cocaine Abuse Medications (A)
- ClinicalTrials.gov ID
- NCT00000271
- Acronym / sponsor ID
- 3881
- Keywords
- Desipramine, cocaine, depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 1995 (actual)
- Primary completion
- Oct 2002 (actual)
- Study completion
- Oct 2002 (actual)
- First posted
- 21 Sep 1999 (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 to measure the effect of desipramine in cocaine abusers selected for major depression or dysthymia.
Detailed description
This is a randomized, 12-week, double-blind, 'placebo-controlled trial of outpatients meeting DSM-III-R criteria for cocaine dependence and major depression or dysthymia (by SCID interview). Participants were treated with desipramine, up to 300 mg per day, or matching placebo. All patients received weekly individual manual-guided relapse prevention therapy. Weekly outcome measures included the Clinical Global Impression Scale, self-reported cocaine use and craving, urine toxicology, and the Hamilton Depression Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desipramine | Experimental | Drug: DesipramineParticipants were treated with desipramine, up to 300 mg per day. All patients received weekly individual manual-guided relapse prevention therapy. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants were treated with matching placebo. All patients received weekly individual manual-guided relapse prevention therapy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Meets DSM-IV criteria for current cocaine dependence.
- Used cocaine at least one day in the past month.
- Currently meets DSM-IV criteria for Major Depression or Dysthymia.
- Depressive disorder is either:
- Age 18-60.
Key exclusion criteria (12 listed)
- Meets DSM-IV criteria for past mania (i.e. bipolar disorder), schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse.
- History of seizures.
- History of allergic reaction to desipramine or imipramine.
- Chronic organic mental disorder.
- Significant current suicidal risk.
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 |
|---|---|---|
| DesipramineAlso: desmethylimipramineParticipants were treated with desipramine, up to 300 mg per day, or matching placebo. All participants received weekly individual manual-guided relapse prevention therapy. | Drug | Desipramine |
| PlaceboParticipants were treated with matching placebo. All participants received weekly individual manual-guided relapse prevention therapy. | Drug | Placebo |
Primary outcome
Cocaine Use
Time frame: Weekly over a 12 week period.
Clinical Global Impression Scale, self-reported cocaine use and craving, urine toxicology.
Depression
Time frame: Bi-weekly over a 12 week period.
Hamilton Depression Scale
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 5 Jul 2017.
- Results publication: PubMed 15913920McDowell D, Nunes EV, Seracini AM, Rothenberg J, Vosburg SK, Ma GJ, Petkova E. Desipramine treatment of cocaine-dependent patients with depression: a placebo-controlled trial. Drug Alcohol Depend. 2005 Nov 1;80(2):209-21. doi: 10.1016/j.drugalcdep.2005.03.026.
- Individual participant dataSharing planned: No
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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.
Herbert Kleber, M.D. principal investigator
New York State Psychiatric Institute
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 Desipramine in people with Cocaine-Related Disorders and Substance-Related Disorders, run by New York State Psychiatric Institute 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 9 inclusion and 12 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 5 Jul 2017. 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?
Cocaine Use (time frame: Weekly over a 12 week period.). The study lists 2 primary outcomes in all. 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 NCT00000271, 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 5 Jul 2017.