Trial · NCT02896712
Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention
NCT02896712, Phase 2, Completed, The University of Texas Health Science Center, Houston; results first posted 2023-02-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention. Trials, record NCT02896712. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02896712
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention
- NCT number
- NCT02896712
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 118 participants, actual
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Cocaine-Related Disorders
- Interventions
- Acceptance and Commitment Therapy (ACT), Drug Counseling (DC), Contingency Management (CM), Placebo, Modafinil
- First posted
- 2016-09-12
- Last updated
- 2023-02-08
- Results first posted
- 2023-02-08
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen | 4 weeks | Urine is assessed for levels of the cocaine metabolite benzoylecgonine (BE), and the drug screen is considered positive for cocaine use if BE level is ≥ 150 ng/mL. |
| Primary | Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen | 12 Weeks | Urine is assessed for levels of the cocaine metabolite benzoylecgonine (BE), and the drug screen is considered positive for cocaine use if BE level is ≥ 150 ng/mL. |
| Secondary | Cocaine Use as Indicated by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back | 4 weeks | Timeline Followback (TLFB) is a method to assess of cocaine use that involves asking study participants to self-report their cocaine use over the past week. |
| Secondary | Cocaine Use as Assessed by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back | 12 Weeks | Timeline Followback (TLFB) is a method to assess of cocaine use that involves asking study participants to self-report their cocaine use over the past week. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen | 4 weeks | Using a modified intention-to-treat plan, data are reported for all participants who completed at least one visit after randomization. | proportion of visits | MEAN |
| PRIMARY | Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen | 12 Weeks | Data are reported for all participants who started phase 2. | proportion of visits | MEAN |
| SECONDARY | Cocaine Use as Indicated by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back | 4 weeks | Using a modified intention-to-treat plan, data are reported for all participants who completed at least one visit after randomization. | proportion of days | MEAN |
| SECONDARY | Cocaine Use as Assessed by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back | 12 Weeks | Data are reported for all participants who started phase 2. | proportion of days | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen | Phase 1: ACT Plus CM | 0.31 | Standard Deviation 0.36 | proportion of visits | |
| Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen | Phase 1: DC Plus CM | 0.24 | Standard Deviation 0.34 | proportion of visits | |
| Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen | ACT Plus CM | 0.67 | Standard Deviation 0.24 | proportion of visits | |
| Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen | ACT Plus CM, With Placebo | 0.22 | Standard Deviation 0.24 | proportion of visits | |
| Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen | ACT Plus CM, With Modafinil | 0.12 | Standard Deviation 0.12 | proportion of visits | |
| Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen | DC Plus CM | 0.70 | Standard Deviation 0.32 | proportion of visits | |
| Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen | DC Plus CM, With Placebo | 0.12 | Standard Deviation 0.15 | proportion of visits | |
| Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen | DC Plus CM, With Modafinil | 0.10 | Standard Deviation 0.15 | proportion of visits | |
| Cocaine Use as Indicated by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back | Phase 1: ACT Plus CM | 0.70 | Standard Deviation 0.23 | proportion of days | |
| Cocaine Use as Indicated by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back | Phase 1: DC Plus CM | 0.66 | Standard Deviation 0.27 | proportion of days |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 | STARTED | Acceptance and Commitment Therapy (ACT) Plus Contingency Management (CM) Only | 18 | |
| Phase 1 | STARTED | ACT Plus CM, With Placebo | 17 | |
| Phase 1 | STARTED | ACT Plus CM, With Modafinil | 19 | |
| Phase 1 | STARTED | Drug Counseling (DC) Plus Contingency Management (CM) Only | 21 | |
| Phase 1 | STARTED | DC Plus CM, With Placebo | 23 | |
| Phase 1 | STARTED | DC Plus CM, With Modafinil | 20 | |
| Phase 1 | COMPLETED | Acceptance and Commitment Therapy (ACT) Plus Contingency Management (CM) Only | 14 | |
| Phase 1 | COMPLETED | ACT Plus CM, With Placebo | 17 | |
| Phase 1 | COMPLETED | ACT Plus CM, With Modafinil | 19 | |
| Phase 1 | COMPLETED | Drug Counseling (DC) Plus Contingency Management (CM) Only | 10 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events248
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Drowsiness | General disorders | Phase 1: Acceptance and Commitment Therapy (ACT) Plus Contingency Management (CM) Only | 0 | 54 | 0 |
| other | Drowsiness | General disorders | Phase 1: Drug Counseling (DC) Plus Contingency Management (CM) Only | 1 | 64 | 4 |
| other | Drowsiness | General disorders | Phase 2: ACT Plus CM Only | 0 | 14 | 0 |
| other | Drowsiness | General disorders | Phase 2: ACT Plus CM, With Placebo | 1 | 17 | 1 |
| other | Drowsiness | General disorders | Phase 2: ACT Plus CM, With Modafinil | 0 | 19 | 0 |
| other | Drowsiness | General disorders | Phase 2: DC Plus CM Only | 0 | 10 | 0 |
| other | Drowsiness | General disorders | Phase 2: DC Plus CM, With Placebo | 1 | 23 | 1 |
| other | Drowsiness | General disorders | Phase 2: DC Plus CM, With Modafinil | 2 | 20 | 5 |
| other | Not Sleeping Well | General disorders | Phase 1: Acceptance and Commitment Therapy (ACT) Plus Contingency Management (CM) Only | 1 | 54 | 1 |
| other | Not Sleeping Well | General disorders | Phase 1: Drug Counseling (DC) Plus Contingency Management (CM) Only | 2 | 64 | 3 |
1 to 10 of 248Source ClinicalTrials.gov
See all 248 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1: Acceptance and Commitment Therapy (ACT) Plus Contingency Management (CM) Only | 0 | 54 |
| Total, all-cause mortality | Phase 1: Drug Counseling (DC) Plus Contingency Management (CM) Only | 0 | 64 |
| Total, all-cause mortality | Phase 2: ACT Plus CM Only | 0 | 14 |
| Total, all-cause mortality | Phase 2: ACT Plus CM, With Placebo | 0 | 17 |
| Total, all-cause mortality | Phase 2: ACT Plus CM, With Modafinil | 0 | 19 |
| Total, all-cause mortality | Phase 2: DC Plus CM Only | 0 | 10 |
| Total, all-cause mortality | Phase 2: DC Plus CM, With Placebo | 0 | 23 |
| Total, all-cause mortality | Phase 2: DC Plus CM, With Modafinil | 0 | 20 |
| Total, other adverse events | Phase 1: Acceptance and Commitment Therapy (ACT) Plus Contingency Management (CM) Only | 11 | 54 |
| Total, other adverse events | Phase 1: Drug Counseling (DC) Plus Contingency Management (CM) Only | 14 | 64 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
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/NCT02896712
GET https://conductscience.org/api/trials/v1/NCT02896712/flow?page=2