Cocaine-Related DisordersPhase 2NCT02896712
Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention
A Phase 2 study testing Acceptance and Commitment Therapy (ACT), Drug Counseling (DC) and Contingency Management (CM) in people with Cocaine-Related Disorders, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
First, the investigators will determine whether Acceptance and Commitment Therapy in combination with Contingency Management increases initial treatment response rates. Second, for patients who do not respond to initial treatment, the investigators will examine whether dopamine-targeted pharmacotherapy is an effective… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cocaine-Related Disorders
- What is being tested?
- Acceptance and Commitment Therapy (ACT), Drug Counseling (DC) and Contingency Management (CM)
- 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
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2016to 13 Sep 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- be between 18 and 60 years of age
- meet DSM-5 criteria for current cocaine use disorder of at least moderate severity (≥ 4 symptoms)
- have at least 1 positive urine BE specimen (≥ 150 ng/mL) during intake
- be in acceptable health on the basis of interview, medical history and physical exam
- agree to use an acceptable method of birth control during study participation and for one month after discontinuation of the study medication. Non-hormonal methods of contraception are recommended, including barrier contraceptives (e.g., diaphragm, cervical cap, male condom) or intrauterine device (IUD). Steroid contraceptives if used with non-hormonal methods are acceptable.
- be able to understand the consent form and provide written informed consent
- be able to provide the names of at least 2 persons who can generally locate their whereabouts.
Who cannot join
- current DSM-5 diagnosis for substance use disorder (of at least moderate severity) other than cocaine, marijuana, or nicotine
- have a DSM-5 axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe (e.g., psychosis, dementia).
- significant current suicidal or homicidal ideation
- medical conditions contraindicating modafinil pharmacotherapy (e.g., major cardiovascular disease, severe liver disease based on Child-Pugh score of B or C, serious kidney problems)
- taking medications that could adversely interact with modafinil (e.g., propranolol, phenytoin, warfarin, diazepam)
- having conditions of probation or parole requiring reports of drug use to officers of the court
Show all 9Show fewer
- impending incarceration
- pregnant or nursing for female patients
- inability to read, write, or speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
UTHealth Center for Neurobehavioral Research on Addiction
Houston, Texas, 77054
About this study
Official title: Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention ("Adaptive Trial")
First, the investigators will determine whether Acceptance and Commitment Therapy in combination with Contingency Management increases initial treatment response rates.
Second, for patients who do not respond to initial treatment, the investigators will examine whether dopamine-targeted pharmacotherapy is an effective augmentation strategy.
Third, for patients who respond to initial treatment, the investigators will assess the relative benefit of continued treatment with Acceptance and Commitment Therapy in combination with Contingency Management, as compared to Drug Counseling in combination with Contingency Management, to prevent relapse.
Read the detailed description
Drug addiction is a chronic, devastating, but treatable disorder, for which there exists a growing armamentarium of evidence-based interventions, including pharmacotherapies and psychotherapies. A core principle of drug addiction treatment, however, states that no single treatment is appropriate for everyone; rather, treatments need to be adjusted based on patient characteristics and response in order to be maximally effective. Ideally, clinicians would identify a sequence of interventions that works best across different stages of addiction treatment, from abstinence initiation to relapse prevention. Adaptive treatment interventions have been used successfully to inform this sequential clinical decision-making process. For cocaine use disorders (CUD), the most potent intervention currently available for initiating abstinence is behavior therapy using contingency management (CM) procedures. Intensive CM has been shown to produce initial cocaine abstinence rates of 40%, unmatched by all other forms of behavioral or pharmacological treatment, making it a prototypical first-line therapy for CUD. Importantly, achievement of initial abstinence predicts future abstinence. For the clinician, these research findings translate into a straightforward question: Can the investigators drive CM response rates even higher with targeted adjunctive interventions?
The proposed sequential, multiple assignment, randomized trial (SMART) will provide the data needed to answer this question. First, the investigators will determine whether Acceptance and Commitment Therapy (ACT) in combination with CM increases initial treatment response rates. The investigators hypothesize that four weeks of treatment with ACT+CM will produce higher abstinence rates than initial treatment combining standard Drug Counseling with CM (DC+CM). The hypothesized synergism of ACT+CM on primary treatment mechanisms of experiential avoidance and reward sensitivity, respectively, will be examined. Second, for patients who do not respond to initial treatment, the investigators will examine whether dopamine-targeted pharmacotherapy is an effective augmentation strategy. Specifically, the investigators hypothesize that continued ACT+CM treatment with modafinil augmentation will be most effective in promoting abstinence relative to treatment combinations involving continued DC and/or placebo. Third, for patients who respond to initial treatment, the investigators will assess the relative benefit of continued treatment with ACT+CM, as compared to DC+CM, to prevent relapse. ACT emphasizes goal-directed actions based on values that are intrinsically motivating, and is thereby expected to be a more effective intervention for extending the duration of abstinence following initial treatment with intensive CM.
- Conditions
- Cocaine-Related Disorders
- Being tested
- Acceptance and Commitment Therapy (ACT), Drug Counseling (DC), Contingency Management (CM), Placebo, Modafinil
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT)Behavioural
Also called ACT
ACT will assist cocaine patients to notice internal cravings and triggers, abandon attempts to manage these triggers via active avoidance, suppression or other control-based strategies, and to make commitments to engage in behaviors consistent with chosen values or goals. ACT encourages clients to experience thoughts and feelings from an observer perspective, and helps clients not to believe distressing thoughts and feelings as if those thoughts and feelings are literally true and in need of action. ACT treatment will be based on the ACT therapy manual developed and tested previously.
Drug Counseling (DC)Behavioural
Also called DC
The investigators will use the manual-guided individual DC modeled after the NIDA Collaborative Cocaine Treatment Study and used as the active control therapy in previous studies. DC approximates clinical practice as it is considered the most common type of evidence-based treatment in the community for patients actively using cocaine.
Contingency Management (CM)Behavioural
Also called CM
The investigators will use the same high-magnitude CM schedule shown previously to be feasible and effective in facilitating initial cocaine abstinence. Subjects will earn vouchers for cocaine-negative urine samples collected at scheduled clinic visits each week. Under an escalating reinforcement schedule, voucher values will begin at $15 and increase by $10 for each consecutive negative urine. Bonus vouchers of $10 will be given for three consecutive negative urines. Provision of a cocaine-positive urine or failure to provide a scheduled sample will result in no vouchers earned and will reset the schedule to the initial value of $15.
PlaceboDrug
Also called Corn Starch
The placebo capsule will be filled with corn starch and riboflavin.
ModafinilDrug
Also called Provigil
Modafinil capsules will start at 200 mg (day 1) and increase to the fixed dose of 300 mg (day 2) and will also contain riboflavin.
| Study group | Role | What they receive |
|---|---|---|
| ACT plus CM | Active comparator | Acceptance and Commitment Therapy along with Contingency Management for cocaine use will be administered to help decrease experiential avoidance while increasing acceptance and willingness to experience unpleasant thoughts, feelings, and physical symptoms. Receives: Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: Contingency Management (CM) |
| ACT plus CM, with Placebo | Active comparator | Acceptance and Commitment Therapy along with Contingency Management for cocaine use will be administered and augmented with a placebo capsule during Phase 2 (weeks 5-12). Receives: Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: Contingency Management (CM); Drug: Placebo |
| ACT plus CM, with Modafinil | Experimental | Acceptance and Commitment Therapy along with Contingency Management for cocaine use will be administered and augmented with a Modafinil (300mg) capsule during Phase 2 (weeks 5-12). Receives: Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: Contingency Management (CM); Drug: Modafinil |
| DC plus CM | Active comparator | Drug Counseling and Contingency Management for cocaine use will be administered to help educate patients about important concepts in addiction recovery. Receives: Behavioral: Drug Counseling (DC); Behavioral: Contingency Management (CM) |
| DC plus CM, with Placebo | Active comparator | Drug Counseling and Contingency Management for cocaine use will be administered and augmented with a placebo capsule during Phase 2 (weeks 5-12). Receives: Behavioral: Drug Counseling (DC); Behavioral: Contingency Management (CM); Drug: Placebo |
| DC plus CM, with Modafinil | Experimental | Drug Counseling and Contingency Management for cocaine use will be administered and augmented with a Modafinil (300mg) capsule during Phase 2 (weeks 5-12). Receives: Behavioral: Drug Counseling (DC); Behavioral: Contingency Management (CM); Drug: Modafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen
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.
Measured: 4 weeks
Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen
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.
Measured: 12 Weeks
Secondary outcomes (2)
Cocaine Use as Indicated by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back
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.
Measured: 4 weeks
Cocaine Use as Assessed by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back
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.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start18 Nov 2016
- Primary completion13 Sep 2021
- Study completion13 Sep 2021
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.
- Publications (6)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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joy Schmitz, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896712
- Sponsor's protocol ID
- HSC-MS-15-0595
- Status last verified
- Jan 2023
- First submitted
- 6 Sep 2016
- Last updated
- 8 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
de Dios C, Webber HE, Wardle MC, Yoon JH, Patriquin MA, Vincent JN, Schmitz JM, Lane SD. Anti-saccade error rates are associated with somatic depressive symptoms in cocaine use disorder. J Psychopharmacol. 2026 Feb;40(2):296-304. doi: 10.1177/02698811251399579. Epub 2025 Dec 26.
PubMed 41451557Nunez C, Yoon JH, de Dios C, Dang V, Lane SD, Vincent JN, Schmitz JM, Wardle MC. Undervaluing nondrug rewards or overvaluing cocaine? Cocaine demand relates to cocaine use severity more strongly than anhedonia in individuals with cocaine use disorder. Exp Clin Psychopharmacol. 2025 Feb;33(1):91-99. doi: 10.1037/pha0000744. Epub 2024 Aug 29.
PubMed 39207396Webber HE, Yoon JH, de Dios C, Suchting R, Dang V, Versace F, Green CE, Wardle MC, Lane SD, Schmitz JM. Assessing cocaine motivational value: Comparison of brain reactivity bias toward cocaine cues and cocaine demand. Exp Clin Psychopharmacol. 2023 Aug;31(4):861-867. doi: 10.1037/pha0000622. Epub 2022 Dec 8.
PubMed 36480395Lathan EC, Hong JH, Heads AM, Borgogna NC, Schmitz JM. Prevalence and Correlates of Sex Selling and Sex Purchasing among Adults Seeking Treatment for Cocaine Use Disorder. Subst Use Misuse. 2021;56(14):2229-2241. doi: 10.1080/10826084.2021.1981391. Epub 2021 Sep 24.
PubMed 34559026Webber HE, de Dios C, Wardle MC, Suchting R, Green CE, Schmitz JM, Lane SD, Versace F. Electrophysiological responses to emotional and cocaine cues reveal individual neuroaffective profiles in cocaine users. Exp Clin Psychopharmacol. 2022 Oct;30(5):514-524. doi: 10.1037/pha0000450. Epub 2021 Feb 25.
PubMed 33630644Yoon JH, Suchting R, McKay SA, San Miguel GG, Vujanovic AA, Stotts AL, Lane SD, Vincent JN, Weaver MF, Lin A, Schmitz JM. Baseline cocaine demand predicts contingency management treatment outcomes for cocaine-use disorder. Psychol Addict Behav. 2020 Feb;34(1):164-174. doi: 10.1037/adb0000475. Epub 2019 Jun 24.
PubMed 31233323
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention ("Adaptive Trial")
- ClinicalTrials.gov ID
- NCT02896712
- Acronym / sponsor ID
- HSC-MS-15-0595
- Conditions
- Cocaine-Related Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 18 Nov 2016
- Primary completion
- 13 Sep 2021 (actual)
- Study completion
- 13 Sep 2021 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Posted 8 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
First, the investigators will determine whether Acceptance and Commitment Therapy in combination with Contingency Management increases initial treatment response rates.
Second, for patients who do not respond to initial treatment, the investigators will examine whether dopamine-targeted pharmacotherapy is an effective augmentation strategy.
Third, for patients who respond to initial treatment, the investigators will assess the relative benefit of continued treatment with Acceptance and Commitment Therapy in combination with Contingency Management, as compared to Drug Counseling in combination with Contingency Management, to prevent relapse.
Detailed description
Drug addiction is a chronic, devastating, but treatable disorder, for which there exists a growing armamentarium of evidence-based interventions, including pharmacotherapies and psychotherapies. A core principle of drug addiction treatment, however, states that no single treatment is appropriate for everyone; rather, treatments need to be adjusted based on patient characteristics and response in order to be maximally effective. Ideally, clinicians would identify a sequence of interventions that works best across different stages of addiction treatment, from abstinence initiation to relapse prevention. Adaptive treatment interventions have been used successfully to inform this sequential clinical decision-making process. For cocaine use disorders (CUD), the most potent intervention currently available for initiating abstinence is behavior therapy using contingency management (CM) procedures. Intensive CM has been shown to produce initial cocaine abstinence rates of 40%, unmatched by all other forms of behavioral or pharmacological treatment, making it a prototypical first-line therapy for CUD. Importantly, achievement of initial abstinence predicts future abstinence. For the clinician, these research findings translate into a straightforward question: Can the investigators drive CM response rates even higher with targeted adjunctive interventions?
The proposed sequential, multiple assignment, randomized trial (SMART) will provide the data needed to answer this question. First, the investigators will determine whether Acceptance and Commitment Therapy (ACT) in combination with CM increases initial treatment response rates. The investigators hypothesize that four weeks of treatment with ACT+CM will produce higher abstinence rates than initial treatment combining standard Drug Counseling with CM (DC+CM). The hypothesized synergism of ACT+CM on primary treatment mechanisms of experiential avoidance and reward sensitivity, respectively, will be examined. Second, for patients who do not respond to initial treatment, the investigators will examine whether dopamine-targeted pharmacotherapy is an effective augmentation strategy. Specifically, the investigators hypothesize that continued ACT+CM treatment with modafinil augmentation will be most effective in promoting abstinence relative to treatment combinations involving continued DC and/or placebo. Third, for patients who respond to initial treatment, the investigators will assess the relative benefit of continued treatment with ACT+CM, as compared to DC+CM, to prevent relapse. ACT emphasizes goal-directed actions based on values that are intrinsically motivating, and is thereby expected to be a more effective intervention for extending the duration of abstinence following initial treatment with intensive CM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ACT plus CM | Active comparator | Behavioral: Acceptance and Commitment Therapy (ACT), Behavioral: Contingency Management (CM)Acceptance and Commitment Therapy along with Contingency Management for cocaine use will be administered to help decrease experiential avoidance while increasing acceptance and willingness to experience unpleasant thoughts, feelings, and physical symptoms. |
| ACT plus CM, with Placebo | Active comparator | Behavioral: Acceptance and Commitment Therapy (ACT), Behavioral: Contingency Management (CM), Drug: PlaceboAcceptance and Commitment Therapy along with Contingency Management for cocaine use will be administered and augmented with a placebo capsule during Phase 2 (weeks 5-12). |
| ACT plus CM, with Modafinil | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT), Behavioral: Contingency Management (CM), Drug: ModafinilAcceptance and Commitment Therapy along with Contingency Management for cocaine use will be administered and augmented with a Modafinil (300mg) capsule during Phase 2 (weeks 5-12). |
| DC plus CM | Active comparator | Behavioral: Drug Counseling (DC), Behavioral: Contingency Management (CM)Drug Counseling and Contingency Management for cocaine use will be administered to help educate patients about important concepts in addiction recovery. |
| DC plus CM, with Placebo | Active comparator | Behavioral: Drug Counseling (DC), Behavioral: Contingency Management (CM), Drug: PlaceboDrug Counseling and Contingency Management for cocaine use will be administered and augmented with a placebo capsule during Phase 2 (weeks 5-12). |
| DC plus CM, with Modafinil | Experimental | Behavioral: Drug Counseling (DC), Behavioral: Contingency Management (CM), Drug: ModafinilDrug Counseling and Contingency Management for cocaine use will be administered and augmented with a Modafinil (300mg) capsule during Phase 2 (weeks 5-12). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- be between 18 and 60 years of age
- meet DSM-5 criteria for current cocaine use disorder of at least moderate severity (≥ 4 symptoms)
- have at least 1 positive urine BE specimen (≥ 150 ng/mL) during intake
- be in acceptable health on the basis of interview, medical history and physical exam
- agree to use an acceptable method of birth control during study participation and for one month after discontinuation of the study medication. Non-hormonal methods of contraception are recommended, including barrier contraceptives (e.g., diaphragm, cervical cap, male condom) or intrauterine device (IUD). Steroid contraceptives if used with non-hormonal methods are acceptable.
Key exclusion criteria (9 listed)
- current DSM-5 diagnosis for substance use disorder (of at least moderate severity) other than cocaine, marijuana, or nicotine
- have a DSM-5 axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe (e.g., psychosis, dementia).
- significant current suicidal or homicidal ideation
- medical conditions contraindicating modafinil pharmacotherapy (e.g., major cardiovascular disease, severe liver disease based on Child-Pugh score of B or C, serious kidney problems)
- taking medications that could adversely interact with modafinil (e.g., propranolol, phenytoin, warfarin, diazepam)
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 |
|---|---|---|
| Acceptance and Commitment Therapy (ACT)Also: ACTACT will assist cocaine patients to notice internal cravings and triggers, abandon attempts to manage these triggers via active avoidance, suppression or other control-based strategies, and to make commitments to engage in behaviors consistent with chosen values or goals. ACT encourages clients to experience thoughts and feelings from an observer perspective, and helps clients not to believe distressing thoughts and feelings as if those thoughts and feelings are literally true and in need of action. ACT treatment will be based on the ACT therapy manual developed and tested previously. | Behavioural | ACT plus CM, ACT plus CM, with Modafinil, ACT plus CM, with Placebo |
| Drug Counseling (DC)Also: DCThe investigators will use the manual-guided individual DC modeled after the NIDA Collaborative Cocaine Treatment Study and used as the active control therapy in previous studies. DC approximates clinical practice as it is considered the most common type of evidence-based treatment in the community for patients actively using cocaine. | Behavioural | DC plus CM, DC plus CM, with Modafinil, DC plus CM, with Placebo |
| Contingency Management (CM)Also: CMThe investigators will use the same high-magnitude CM schedule shown previously to be feasible and effective in facilitating initial cocaine abstinence. Subjects will earn vouchers for cocaine-negative urine samples collected at scheduled clinic visits each week. Under an escalating reinforcement schedule, voucher values will begin at $15 and increase by $10 for each consecutive negative urine. Bonus vouchers of $10 will be given for three consecutive negative urines. Provision of a cocaine-positive urine or failure to provide a scheduled sample will result in no vouchers earned and will reset the schedule to the initial value of $15. | Behavioural | ACT plus CM, ACT plus CM, with Modafinil, ACT plus CM, with Placebo, DC plus CM, DC plus CM, with Modafinil, DC plus CM, with Placebo |
| PlaceboAlso: Corn StarchThe placebo capsule will be filled with corn starch and riboflavin. | Drug | ACT plus CM, with Placebo, DC plus CM, with Placebo |
| ModafinilAlso: ProvigilModafinil capsules will start at 200 mg (day 1) and increase to the fixed dose of 300 mg (day 2) and will also contain riboflavin. | Drug | ACT plus CM, with Modafinil, DC plus CM, with Modafinil |
Primary outcome
Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen
Time frame: 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.
Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen
Time frame: 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.
2 secondary outcomes
Cocaine Use as Indicated by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back
Time frame: 4 weeks
Cocaine Use as Assessed by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back
Time frame: 12 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41451557de Dios C, Webber HE, Wardle MC, Yoon JH, Patriquin MA, Vincent JN, Schmitz JM, Lane SD. Anti-saccade error rates are associated with somatic depressive symptoms in cocaine use disorder. J Psychopharmacol. 2026 Feb;40(2):296-304. doi: 10.1177/02698811251399579. Epub 2025 Dec 26.
- Derived from this study: PubMed 39207396Nunez C, Yoon JH, de Dios C, Dang V, Lane SD, Vincent JN, Schmitz JM, Wardle MC. Undervaluing nondrug rewards or overvaluing cocaine? Cocaine demand relates to cocaine use severity more strongly than anhedonia in individuals with cocaine use disorder. Exp Clin Psychopharmacol. 2025 Feb;33(1):91-99. doi: 10.1037/pha0000744. Epub 2024 Aug 29.
- Derived from this study: PubMed 36480395Webber HE, Yoon JH, de Dios C, Suchting R, Dang V, Versace F, Green CE, Wardle MC, Lane SD, Schmitz JM. Assessing cocaine motivational value: Comparison of brain reactivity bias toward cocaine cues and cocaine demand. Exp Clin Psychopharmacol. 2023 Aug;31(4):861-867. doi: 10.1037/pha0000622. Epub 2022 Dec 8.
- Derived from this study: PubMed 34559026Lathan EC, Hong JH, Heads AM, Borgogna NC, Schmitz JM. Prevalence and Correlates of Sex Selling and Sex Purchasing among Adults Seeking Treatment for Cocaine Use Disorder. Subst Use Misuse. 2021;56(14):2229-2241. doi: 10.1080/10826084.2021.1981391. Epub 2021 Sep 24.
- Derived from this study: PubMed 33630644Webber HE, de Dios C, Wardle MC, Suchting R, Green CE, Schmitz JM, Lane SD, Versace F. Electrophysiological responses to emotional and cocaine cues reveal individual neuroaffective profiles in cocaine users. Exp Clin Psychopharmacol. 2022 Oct;30(5):514-524. doi: 10.1037/pha0000450. Epub 2021 Feb 25.
- Derived from this study: PubMed 31233323Yoon JH, Suchting R, McKay SA, San Miguel GG, Vujanovic AA, Stotts AL, Lane SD, Vincent JN, Weaver MF, Lin A, Schmitz JM. Baseline cocaine demand predicts contingency management treatment outcomes for cocaine-use disorder. Psychol Addict Behav. 2020 Feb;34(1):164-174. doi: 10.1037/adb0000475. Epub 2019 Jun 24.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acceptance and Commitment Therapy (ACT), Drug Counseling (DC) and Contingency Management (CM) in people with Cocaine-Related Disorders, run by The University of Texas Health Science Center, Houston 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 7 inclusion and 9 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 8 Feb 2023. 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. 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 8 Feb 2023). 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?
Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen (time frame: 4 weeks). 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 NCT02896712, which also lists 6 linked publications.
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 8 Feb 2023.