Trial · NCT00430573
Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use
NCT00430573, Phase 2, Terminated, Boston University Charles River Campus; results first posted 2018-05-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use. Trials, record NCT00430573. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00430573
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use
- NCT number
- NCT00430573
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Boston University Charles River Campus
- Conditions
- Substance-Related Disorders
- Interventions
- D-cycloserine, Placebo
- First posted
- 2007-02-02
- Last updated
- 2018-05-17
- Results first posted
- 2018-05-17
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Positive Toxicology Swabs for Illicit Substances | 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. |
| Secondary | Addiction Severity Index (ASI) Drug Use Composite Score | Baseline, Mid Treatment (week 6), End of Treatment (week 12), Follow-up 1 (week 15), Follow-up 2 (week 18) | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Positive Toxicology Swabs for Illicit Substances | Weekly assessments with summation over three time periods: baseline, treatment (week 12), and follow-up (week 18) | 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. | percentage of positive toxicology swabs | MEAN |
| SECONDARY | Addiction Severity Index (ASI) Drug Use Composite Score | Baseline, Mid Treatment (week 6), End of Treatment (week 12), Follow-up 1 (week 15), Follow-up 2 (week 18) | All randomized participants were asked to complete the ASI irrespective of taking study drug. At least one ASI was completed by 8 of the 10 randomized participants. At baseline 8 completed the ASI and the number of participants at each subsequent time point varied. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Positive Toxicology Swabs for Illicit Substances | All Randomized Participants | Baseline Period | 80.0 | Standard Deviation 35.0 | percentage of positive toxicology swabs |
| Percentage of Positive Toxicology Swabs for Illicit Substances | All Randomized Participants | Treatment Period (week12) | 65.7 | Standard Deviation 45.8 | percentage of positive toxicology swabs |
| Percentage of Positive Toxicology Swabs for Illicit Substances | All Randomized Participants | Follow-up Period (week 18) | 59.6 | Standard Deviation 44.1 | percentage of positive toxicology swabs |
| Addiction Severity Index (ASI) Drug Use Composite Score | Randomized Participants That Completed Baseline ASI | Baseline | 0.27 | Standard Deviation 0.14 | units on a scale |
| Addiction Severity Index (ASI) Drug Use Composite Score | Randomized Participants That Completed Baseline ASI | Mid-Treatment (week 6) | 0.19 | Standard Deviation 0.12 | units on a scale |
| Addiction Severity Index (ASI) Drug Use Composite Score | Randomized Participants That Completed Baseline ASI | Endpoint of Treatment (week 12) | 0.21 | Standard Deviation 0.13 | units on a scale |
| Addiction Severity Index (ASI) Drug Use Composite Score | Randomized Participants That Completed Baseline ASI | Follow-Up 1 (week 15) | 0.30 | Standard Deviation 0.06 | units on a scale |
| Addiction Severity Index (ASI) Drug Use Composite Score | Randomized Participants That Completed Baseline ASI | Follow-Up 2 (week 18) | 0.18 | Standard Deviation 0.18 | units on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Randomized Participants | 10 | |
| Overall Study | COMPLETED | All Randomized Participants | 5 | |
| Overall Study | NOT COMPLETED | All Randomized Participants | 5 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Randomized Participants | 0 | 10 |
| Total, other adverse events | All Randomized Participants | 0 | 10 |
| Total, serious adverse events | All Randomized Participants | 0 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DA017904 | Stress, Distress Intolerance, and Drug Dependence | OTTO, MICHAEL W. | BOSTON UNIVERSITY (CHARLES RIVER CAMPUS) | NATIONAL INSTITUTE ON DRUG ABUSE | 2004 to 2008 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00430573
GET https://conductscience.org/api/trials/v1/NCT00430573/registered