Substance-Related DisordersPhase 2NCT00430573

Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use

A Phase 2 study testing D-cycloserine in people with Substance-Related Disorders, run by Boston University Charles River Campus at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This study examines whether isolated doses of d-cycloserine enhance the efficacy of an exposure-based cognitive-behavioral treatment for chronic and treatment refractory substance dependence. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Substance-Related Disorders
What is being tested?: D-cycloserine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Feb 2007to Jun 2009
Phase: Phase 2
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The primary selection criteria include women and men between the ages of 18 and 65 who:
Meet DSM-IV criteria for opiate dependence,
Maintain a stable dose of methadone for two weeks prior to recruitment and:
fail to achieve "take-home" status for methadone dosing during at least the first four months of methadone treatment,
test positive on at least two toxicology screens for illicit drugs during the month prior to recruitment
have never achieved two consecutive toxicology screens free of illicit substances since entering the current treatment episode.

Show all 9Show fewer

Meet study criteria for chronic stress:
unemployment criteria, and
affective disorder criteria.

Who cannot join

Patients with significantly unstable or uncontrolled medical illness which may interfere with participation in treatment (e.g., patients likely to require hospitalization during the study period).
Patients with a psychotic or organic mental disorder according to DSM-IV criteria.
Patients receiving medication affecting methadone metabolism (e.g. rifampin).
Patients with uncontrolled bipolar disorder as evidenced by meeting current criteria for mania or hypomania or meeting criteria for rapid cycling in the last year (as indicated by structured questioning of all patients meeting criteria for bipolar disorder).
Patients unable to complete the informed consent or unable to understand study procedures in the informed consent process.
Pregnancy or current alcohol use.

Trial locations and contacts

1 site in 1 country.

United States1 site

Habit OPCO
Boston, Massachusetts, 02118

Other trials in United States

About this study

Official title: Placebo-Controlled Evaluation of the Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use

This study examines whether isolated doses of d-cycloserine enhance the efficacy of an exposure-based cognitive-behavioral treatment for chronic and treatment refractory substance dependence.

Read the detailed description

This is a placebo-controlled trial of the efficacy of 50mg d-cycloserine or matching pill placebo for enhancing the efficacy of CBT.

Conditions: Substance-Related Disorders
Being tested: D-cycloserine, Placebo
Keywords: cognitive-behavior therapy, d-cycloserine, cognitive enhancer, drug dependence, opiate dependence, exposure, isolated doses of d-cycloserine, isolated doses of matching pill placebo, DCS
Medical subject headings: Substance-Related Disorders, Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

D-cycloserineDrug
Also called DCS
Single dosage of D-cycloserine is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)
PlaceboDrug
Single dosage of placebo is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)

Study groups in NCT00430573
Study group	Role	What they receive
DCS-augmented CBT-IC	Experimental	D-cycloserine-augmented CBT-IC Receives: Drug: D-cycloserine
Placebo-augmented CBT-IC	Placebo comparator	Placebo-augmented CBT-IC Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Positive Toxicology Swabs for Illicit Substances
The primary outcome assessment for this study was the percentage of oral toxicology swabs that were positive of illicit substances. Participants completed these swabs at each assessment point, as well as at each study therapy session. Toxicology swabs were supervised by study staff and used oral specimen collection to screen for opiates, methadone, cocaine, benzodiazepines, amphetamines, THC, and barbiturates.
Measured: Weekly assessments with summation over three time periods: baseline, treatment (week 12), and follow-up (week 18)

Secondary outcomes (1)

Addiction Severity Index (ASI) Drug Use Composite Score
For the drug use composite scores, each of 13 questions about drug use is divided by its maximum answer value and by the total number of questions in the composite. These individual items are then summed, so that possible total scores range from 0 to 1, with higher scores reflecting greater drug use problem severity.
Measured: Baseline, Mid Treatment (week 6), End of Treatment (week 12), Follow-up 1 (week 15), Follow-up 2 (week 18)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Jun 2009

First posted2 Feb 2007 (estimated)
Study startFeb 2007
Primary completionJun 2009
Study completionJun 2009

Why it stopped: The investigators failed to recruit participants as originally projected.

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.
Other trials for Substance-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: Double blind
Who is masked: Participant, Investigator
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00430573
Sponsor's protocol ID: R01 DA017904-S1
Other IDs: R01DA017904
Status last verified: May 2018
First submitted: 31 Jan 2007
Last updated: 17 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication

All Substance-Related Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Placebo-Controlled Evaluation of the Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use
ClinicalTrials.gov ID: NCT00430573
Acronym / sponsor ID: R01 DA017904-S1
Conditions: Substance-Related Disorders
Keywords: cognitive-behavior therapy, d-cycloserine, cognitive enhancer, drug dependence, opiate dependence, exposure, isolated doses of d-cycloserine, isolated doses of matching pill placebo
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The investigators failed to recruit participants as originally projected.
Enrolment: 15 participants (actual)
Lead sponsor: Boston University Charles River CampusUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA), Massachusetts General Hospital
Study start: Feb 2007 (actual)
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 2 Feb 2007 (estimated)
Results: Posted 17 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study examines whether isolated doses of d-cycloserine enhance the efficacy of an exposure-based cognitive-behavioral treatment for chronic and treatment refractory substance dependence.

Detailed description

This is a placebo-controlled trial of the efficacy of 50mg d-cycloserine or matching pill placebo for enhancing the efficacy of CBT.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
DCS-augmented CBT-IC	Experimental	Drug: D-cycloserineD-cycloserine-augmented CBT-IC
Placebo-augmented CBT-IC	Placebo comparator	Drug: PlaceboPlacebo-augmented CBT-IC

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Meet DSM-IV criteria for opiate dependence,
Maintain a stable dose of methadone for two weeks prior to recruitment and:
Meet study criteria for chronic stress:

Key exclusion criteria (6 listed)

Patients with significantly unstable or uncontrolled medical illness which may interfere with participation in treatment (e.g., patients likely to require hospitalization during the study period).
Patients with a psychotic or organic mental disorder according to DSM-IV criteria.
Patients receiving medication affecting methadone metabolism (e.g. rifampin).
Patients with uncontrolled bipolar disorder as evidenced by meeting current criteria for mania or hypomania or meeting criteria for rapid cycling in the last year (as indicated by structured questioning of all patients meeting criteria for bipolar disorder).
Patients unable to complete the informed consent or unable to understand study procedures in the informed consent process.

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
D-cycloserineAlso: DCSSingle dosage of D-cycloserine is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)	Drug	DCS-augmented CBT-IC
PlaceboSingle dosage of placebo is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)	Drug	Placebo-augmented CBT-IC

Primary outcome

Percentage of Positive Toxicology Swabs for Illicit Substances
Time frame: Weekly assessments with summation over three time periods: baseline, treatment (week 12), and follow-up (week 18)
The primary outcome assessment for this study was the percentage of oral toxicology swabs that were positive of illicit substances. Participants completed these swabs at each assessment point, as well as at each study therapy session. Toxicology swabs were supervised by study staff and used oral specimen collection to screen for opiates, methadone, cocaine, benzodiazepines, amphetamines, THC, and barbiturates.

1 secondary outcome

Addiction Severity Index (ASI) Drug Use Composite Score
Time frame: Baseline, Mid Treatment (week 6), End of Treatment (week 12), Follow-up 1 (week 15), Follow-up 2 (week 18)

Results and safety

Results posted to the registry on 17 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Randomized Participants	10	5

Primary outcome: Percentage of Positive Toxicology Swabs for Illicit Substances

Time frame: Weekly assessments with summation over three time periods: baseline, treatment (week 12), and follow-up (week 18). Mean (Standard Deviation). Unit: percentage of positive toxicology swabs

Measure	All Randomized Participants n = 10
Baseline Period	80.0 (35.0)
Treatment Period (week12)	65.7 (45.8)
Follow-up Period (week 18)	59.6 (44.1)

Population analysed: Toxicology swabs were obtained on all 10 randomized participants irrespective of taking study drug. At baseline all 10 had toxicology swabs, at treatment (week 12) 7 had toxicology swabs and at follow-up (week 18) 7 had toxicology swabs.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: One year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Randomized Participants	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Limitations and caveats (from the sponsor): Study was terminated due to low enrollment/adherence with the study drug. 10 participants were randomized, 5 dropped out before taking study drug. The blind was never broken so results can only be presented aggregated for all randomized participants.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Substance-Related Disorders

Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication

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 W. Otto, Ph.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 D-cycloserine in people with Substance-Related Disorders, run by Boston University Charles River Campus 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 6 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: stopped early, as of the sponsor's last update on 17 May 2018. 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?

Yes. Results are posted in the registry (first posted 17 May 2018). 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?

Percentage of Positive Toxicology Swabs for Illicit Substances (time frame: Weekly assessments with summation over three time periods: baseline, treatment (week 12), and follow-up (week 18)). 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 NCT00430573.

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 17 May 2018.