CompletedNCT02896712Updated Feb 8, 2023Results posted

Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention

A Phase 2 interventional study of Acceptance and Commitment Therapy (ACT) and Drug Counseling (DC) in Cocaine-Related Disorders, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by The University of Texas Health Science Center, Houston · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 118
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study 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 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 studied

Cocaine-Related Disorders

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In context

Cocaine-Related Disorders

415 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.

This study's enrollment of 118 is above the median of 60 across 312 interventional studies indexed under Cocaine-Related Disorders.

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Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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
impending incarceration
pregnant or nursing for female patients
inability to read, write, or speak English

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 118 participants (actual)

Study arms

Active comparator
ACT plus 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.
Behavioral: Acceptance and Commitment Therapy (ACT) · Behavioral: Contingency Management (CM)
Active comparator
ACT plus CM, with Placebo
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).
Behavioral: Acceptance and Commitment Therapy (ACT) · Behavioral: Contingency Management (CM) · Drug: Placebo
Experimental
ACT plus CM, with Modafinil
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).
Behavioral: Acceptance and Commitment Therapy (ACT) · Behavioral: Contingency Management (CM) · Drug: Modafinil
Active comparator
DC plus CM
Drug Counseling and Contingency Management for cocaine use will be administered to help educate patients about important concepts in addiction recovery.
Behavioral: Drug Counseling (DC) · Behavioral: Contingency Management (CM)
Active comparator
DC plus CM, with Placebo
Drug Counseling and Contingency Management for cocaine use will be administered and augmented with a placebo capsule during Phase 2 (weeks 5-12).
Behavioral: Drug Counseling (DC) · Behavioral: Contingency Management (CM) · Drug: Placebo
Experimental
DC plus CM, with Modafinil
Drug Counseling and Contingency Management for cocaine use will be administered and augmented with a Modafinil (300mg) capsule during Phase 2 (weeks 5-12).
Behavioral: Drug Counseling (DC) · Behavioral: Contingency Management (CM) · Drug: Modafinil

Interventions

BehavioralAcceptance and Commitment Therapy (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.
Also known as: ACT
BehavioralDrug Counseling (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.
Also known as: DC
BehavioralContingency Management (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.
Also known as: CM
DrugPlacebo
The placebo capsule will be filled with corn starch and riboflavin.
Also known as: Corn Starch
DrugModafinil
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.
Also known as: Provigil

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 12 Weeks

Secondary outcomes

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.
Time frame: 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.
Time frame: 12 Weeks

Results

Posted Feb 8, 2023

Participant flow

Phase 1

Participant flow — Phase 1
Milestone	Acceptance and Commitment Therapy (ACT) Plus Contingency Management (CM) Only	ACT Plus CM, With Placebo	ACT Plus CM, With Modafinil	Drug Counseling (DC) Plus Contingency Management (CM) Only	DC Plus CM, With Placebo	DC Plus CM, With Modafinil
Started	18	17	19	21	23	20
Completed	14	17	19	10	23	20
Not completed	4	0	0	11	0	0

Phase 2

Participant flow — Phase 2
Milestone	Acceptance and Commitment Therapy (ACT) Plus Contingency Management (CM) Only	ACT Plus CM, With Placebo	ACT Plus CM, With Modafinil	Drug Counseling (DC) Plus Contingency Management (CM) Only	DC Plus CM, With Placebo	DC Plus CM, With Modafinil
Started	14	17	19	10	23	20
Completed	8	11	10	9	13	13
Not completed	6	6	9	1	10	7

Outcome measures

PrimaryCocaine 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.

Time frame:: 4 weeks
Reported as:: Mean · proportion of visits

Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen
proportion of visits	Phase 1: ACT Plus CM	Phase 1: DC Plus CM
Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen	0.31 ± 0.36	0.24 ± 0.34

PrimaryCocaine 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.

Time frame:: 12 Weeks
Reported as:: Mean · proportion of visits

Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen
proportion of visits	ACT Plus CM	ACT Plus CM, With Placebo	ACT Plus CM, With Modafinil	DC Plus CM	DC Plus CM, With Placebo	DC Plus CM, With Modafinil
Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen	0.67 ± 0.24	0.22 ± 0.24	0.12 ± 0.12	0.70 ± 0.32	0.12 ± 0.15	0.10 ± 0.15

SecondaryCocaine 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.

Time frame:: 4 weeks
Reported as:: Mean · proportion of days

Cocaine Use as Indicated by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back
proportion of days	Phase 1: ACT Plus CM	Phase 1: DC Plus CM
Cocaine Use as Indicated by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back	0.70 ± 0.23	0.66 ± 0.27

SecondaryCocaine 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.

Time frame:: 12 Weeks
Reported as:: Mean · proportion of days

Cocaine Use as Assessed by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back
proportion of days	ACT Plus CM	ACT Plus CM, With Placebo	ACT Plus CM, With Modafinil	DC Plus CM	DC Plus CM, With Placebo	DC Plus CM, With Modafinil
Cocaine Use as Assessed by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back	0.83 ± 0.10	0.58 ± 0.31	0.70 ± 0.16	0.88 ± 0.11	0.63 ± 0.27	0.64 ± 0.27

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Phase 1: Acceptance and Commitment Therapy (ACT) Plus Contingency Management (CM) Only	0/54 (0%)	3/54 (5.6%)	11/54 (20.4%)
Phase 1: Drug Counseling (DC) Plus Contingency Management (CM) Only	0/64 (0%)	1/64 (1.6%)	14/64 (21.9%)
Phase 2: ACT Plus CM Only	0/14 (0%)	0/14 (0%)	2/14 (14.3%)
Phase 2: ACT Plus CM, With Placebo	0/17 (0%)	0/17 (0%)	10/17 (58.8%)
Phase 2: ACT Plus CM, With Modafinil	0/19 (0%)	0/19 (0%)	8/19 (42.1%)
Phase 2: DC Plus CM Only	0/10 (0%)	1/10 (10%)	0/10 (0%)
Phase 2: DC Plus CM, With Placebo	0/23 (0%)	0/23 (0%)	10/23 (43.5%)
Phase 2: DC Plus CM, With Modafinil	0/20 (0%)	3/20 (15%)	14/20 (70%)

Most frequent serious events

Most frequent serious events
Event	Phase 1: Acceptance and Commitment Therapy (ACT) Plus Contingency Management (CM) Only	Phase 1: Drug Counseling (DC) Plus Contingency Management (CM) Only	Phase 2: ACT Plus CM Only	Phase 2: ACT Plus CM, With Placebo	Phase 2: ACT Plus CM, With Modafinil	Phase 2: DC Plus CM Only	Phase 2: DC Plus CM, With Placebo	Phase 2: DC Plus CM, With Modafinil
Suicidal IdeationPsychiatric disorders	1/54	0/64	0/14	0/17	0/19	1/10	0/23	0/20
Asthma AttackRespiratory, thoracic and mediastinal disorders	0/54	0/64	0/14	0/17	0/19	0/10	0/23	1/20
Upper Respiratory InfectionRespiratory, thoracic and mediastinal disorders	0/54	0/64	0/14	0/17	0/19	0/10	0/23	1/20
Symptoms of Congestive Heart FailureCardiac disorders	0/54	1/64	0/14	0/17	0/19	0/10	0/23	1/20
Domestic Violence/AbuseSocial circumstances	1/54	0/64	0/14	0/17	0/19	0/10	0/23	0/20
Stomach FluGastrointestinal disorders	1/54	0/64	0/14	0/17	0/19	0/10	0/23	0/20

Most frequent other events

Showing 10 of 25

Most frequent other events
Event	Phase 1: Acceptance and Commitment Therapy (ACT) Plus Contingency Management (CM) Only	Phase 1: Drug Counseling (DC) Plus Contingency Management (CM) Only	Phase 2: ACT Plus CM Only	Phase 2: ACT Plus CM, With Placebo	Phase 2: ACT Plus CM, With Modafinil	Phase 2: DC Plus CM Only	Phase 2: DC Plus CM, With Placebo	Phase 2: DC Plus CM, With Modafinil
Not Sleeping WellGeneral disorders	1/54	2/64	1/14	2/17	0/19	0/10	1/23	0/20
HeadacheGeneral disorders	2/54	0/64	0/14	2/17	0/19	0/10	0/23	0/20
Muscle AchesMusculoskeletal and connective tissue disorders	1/54	2/64	0/14	2/17	1/19	0/10	1/23	2/20
DrowsinessGeneral disorders	0/54	1/64	0/14	1/17	0/19	0/10	1/23	2/20
Blurry VisionEye disorders	0/54	0/64	0/14	0/17	0/19	0/10	1/23	2/20
WeaknessGeneral disorders	0/54	0/64	0/14	0/17	0/19	0/10	0/23	2/20
FatigueGeneral disorders	0/54	1/64	0/14	0/17	1/19	0/10	0/23	2/20
SweatingGeneral disorders	0/54	0/64	0/14	0/17	0/19	0/10	2/23	0/20
Change in Sexual FunctionGeneral disorders	0/54	0/64	1/14	0/17	0/19	0/10	0/23	0/20
NervousnessGeneral disorders	0/54	0/64	0/14	1/17	1/19	0/10	0/23	0/20

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Phase 1: ACT Plus CM	Phase 1: DC Plus CM	Total
Mean	47.48 ± 8.74	51.58 ± 6.58	49.7 ± 7.88

Sex: Female, Male
Sex: Female, Male(Participants)	Phase 1: ACT Plus CM	Phase 1: DC Plus CM	Total
Female	12	12	24
Male	42	52	94

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Phase 1: ACT Plus CM	Phase 1: DC Plus CM	Total
Hispanic or Latino	6	6	12
Not Hispanic or Latino	48	58	106
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Phase 1: ACT Plus CM	Phase 1: DC Plus CM	Total
American Indian or Alaska Native	0	0	0
Asian	2	0	2
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	43	49	92
White	3	13	16
More than one race	3	1	4
Unknown or Not Reported	3	1	4

Region of Enrollment
Region of Enrollment(participants)	Phase 1: ACT Plus CM	Phase 1: DC Plus CM	Total
United States	54	64	118

Study locations

1 site

UTHealth Center for Neurobehavioral Research on Addiction
Houston, Texas 77054, United States

References and documents

Publications

Lathan 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 34559026 ↗
Webber 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 33630644 ↗
Yoon 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 documents

Protocol and statistical analysis plan · Jun 15, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02896712
Lead sponsor: The University of Texas Health Science Center, Houston
Responsible party: Joy Schmitz (Professor and CNRA Director, The University of Texas Health Science Center, Houston) — Principal investigator
First posted: Sep 12, 2016
Start date: Nov 18, 2016
Primary completion: Sep 13, 2021
Completion: Sep 13, 2021
Results posted: Feb 8, 2023
Last update: Feb 8, 2023

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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