Cocaine Use DisorderCIICNCT03656653
Imagery-based Coping for Cocaine Use Disorder
A study testing Mental Imagery for Craving Reduction in people with Cocaine Use Disorder, run by King's College London at 1 site in United Kingdom.
Trial summary
A pragmatic, 4-week, 4-group, between-subjects, factorial randomised controlled trial conducted at a specialist NHS outpatient addictions clinic and hospital clinical research facility to determine if mental imagery (of past and future positive [recovery oriented] and negative [cocaine aversive] events) can help… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- Mental Imagery for Craving Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Oct 2018to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (18 years and over; no upper limit);
- English speaking (to a level sufficient to engage with a psychosocial intervention);
- Current diagnosis for primary CUD alone, with concurrent opiate use disorder or while enrolled in opioid agonist therapy *
- Self-reported regular use of crack cocaine;
- Stated motivation to reduce or quit cocaine use;
Who cannot join
- Current post-traumatic stress disorder (PTCI score >100);
- Suicide attempt in the past 3 months;
- Participants with harmful alcohol consumption (>50 units per week men; >35 units women);
- Cocaine hydrochloride (powder form) users; **
- Non-English Speaking;
- Clinically significant on-going medical problems that might make participation unsafe;
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- Uncontrolled Mental Health Disorder;
- Severe neurocognitive impairment (Montreal Cognitive Assessment <17);
- Current enrolment in an addiction treatment related clinical research study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Lorraine Hewitt House
London, SW9 8DG
Luke Mitcheson, DCLinPsy, 020 3228, Luke.Mitcheson@slam.nhs.uk
About this study
Official title: Clinical Study of Imagery-based Coping for Cocaine Use Disorder
A pragmatic, 4-week, 4-group, between-subjects, factorial randomised controlled trial conducted at a specialist NHS outpatient addictions clinic and hospital clinical research facility to determine if mental imagery (of past and future positive [recovery oriented] and negative [cocaine aversive] events) can help reduce cue-induced cocaine craving and cocaine use.
Read the detailed description
Cocaine, a powerful stimulant drug, is used by 2.2% of people aged 16-59 in England and each year about 150.000 people seek help for cocaine use disorder from the NHS or non-governmental organisations (NGO). There are currently no approved medication-assisted treatments or specific psychosocial interventions for CUD. General counselling is offered by the NHS and NGO addiction services, but this is not particularly effective.
The transition from regular cocaine use to cocaine abuse is often marked by intense episodes (binges), which may last several days and are followed by a 'crash' with no or little use. For many people, repeated administration of cocaine over a short duration of time creates vivid episodic memories of euphoria which can inform future craving content. Craving or strong urges are a distinctive feature of CUD and are often reported as involuntary, distressing and uncontrollable.
Research has demonstrated that craving experiences can be voluntarily evoked or elicited by conditioned drug cues in the environment and internal processes such mood or physical sensations. The associations between cues and use are established through classical and instrumental reward-based conditioning and are important for the development and maintenance of CUD. Enhanced attention to cocaine cues develops and remains heightened for at least six months into abstinence.
Craving-related experiences are informed by memories of intense reward, physical sensations and include pro-drug beliefs, appraisals, expectancies and vivid mental imagery. Drug-imagery is often initially pleasurable and affectively charged and can motivate drug-seeking behaviour. If impeded or delayed, drug imagery highlights a deficit and can be experienced as distressing and intrusive. Treatment of intrusive images has been successful in various psychological disorders using imagery rescripting. Imagery rescripting has recently been used in memory-focused cognitive therapy to help reduce cocaine craving. Reducing intrusive image-induced negative affect through positive imagery is important for relieving psychological distress but there is also evidence that aversive imagery may reduce maladaptive approach behaviours.
This will be a pragmatic, 4-week, 2x2, between-subjects, factorial randomised controlled trial. It will be conducted at a specialist NHS outpatient addictions clinic (Lorraine Hewitt House; LHH) operated by South London and Maudsley NHS Foundation trust (SLaM) and at the NIHR Wellcome Trust King's Clinical Research Facility (CRF) at King's College Hospital.
Informed consenting adult participants will be randomised to one of four conditions:
- future-based (prospective) recovery-oriented imagery;
- future-based (prospective) cocaine-aversive imagery;
- past (autobiographical) recovery-oriented imagery; or
- past (autobiographical) cocaine-aversive imagery.
Participants will undergo a craving induction procedure designed to elicit cue-induced craving. In response to elevated craving, participants will be asked to reduce their craving levels using a mental imagery intervention.
Following the procedure in the research facility, participants will be given a digital audio player to take home. This will contain a recording of the imagery condition they are allocated to. Participants will be asked to listen to this recording each day during a 14-day follow-up, and ad libertatem when experiencing cocaine craving. After 14 days participants will be invited for a follow up conducted at the community addictions clinic.
- Conditions
- Cocaine Use Disorder
- Being tested
- Mental Imagery for Craving Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Imagery for Craving ReductionBehavioural
a behavioural mental imagery intervention where participants are asked to generate specific mental images to reduce cue-induced craving for cocaine use disorder
| Study group | Role | What they receive |
|---|---|---|
| Future-based recovery-oriented imagery | Experimental | Mental Imagery for Craving Reduction: mental imagery aimed at describing a future without cocaine use Receives: Behavioral: Mental Imagery for Craving Reduction |
| Future-based cocaine-aversive imagery | Experimental | Mental Imagery for Craving Reduction: mental imagery aimed at describing a future where cocaine is causing significant distress Receives: Behavioral: Mental Imagery for Craving Reduction |
| Past recovery-oriented imagery | Experimental | Mental Imagery for Craving Reduction: mental imagery aimed at describing a past event without cocaine use Receives: Behavioral: Mental Imagery for Craving Reduction |
| Past cocaine-aversive imagery | Experimental | Mental Imagery for Craving Reduction: mental imagery aimed at describing a past event where cocaine use has caused significant distress Receives: Behavioral: Mental Imagery for Craving Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Number of Days abstinent from Cocaine
The primary outcome measure will be number of days abstinent from cocaine (percentage). A higher percentage indicates a higher number of abstinent days from cocaine.
This will be expressed as the cumulative distribution function for change (between baseline and follow-up) using a Timeline Follow Back method (calendar prompt).
Percentage days abstinent is measured for two weeks before the first assessment and two weeks post craving-induction procedure.
Measured: baseline (Week 0) and at two week-follow up (Week 4)
Secondary outcomes (13)
Change from baseline in Craving Experience Questionnaire Score (CEQ-12)
The CEQ-12 is an 12-item, self-report instrument measuring intensity, imagery and intrusiveness dimensions of craving. Each item is rated on a 11-point scale (0-10), ranging from 0-120, where a higher score expresses increased craving.
The intensity subscale ranges from 0 to 30 where 30 indicates a constant urge to use cocaine.
The imagery subscale ranges from 0 to 60 where 60 indicates a constant sensory craving experience The intrusiveness subscale ranges from 0 to 30 where 30 indicates constant intrusive thoughts about cocaine
The CEQ-12 is measured at baseline (craving for past 2 weeks) and at two week-follow up (craving for past two weeks)
The total craving score will be expressed as cumulative distribution function for change in cocaine craving.
Measured: baseline (Week 0) and at two week-follow up (Week 4)
Urine toxicology Screening (UDS)
By instant result immunoassay device for cocaine metabolite (benzoylecgonine) and morphine (Alere Toxicology).
Measured: Assessed at two-week follow up (Week 4)
Imagery Monitoring Diary
A monitoring diary used by participants to indicate use of guided imagery audio and changes in craving levels. Diary will be used daily throughout 14-day follow-up period.
Measured: Diary assessed at two-week follow up (Week 4)
Heart Rate Variability (HRV)
Real-time HRV data will be acquired through an E4 Empatica (www.empatica.com) wristband placed on the participants' wrist during the craving induction procedure and imagery intervention conducted at the clinical research facility. the HRV is derived from blood volume pulse and will be computed using the mean differences and peak values of the parameters.
Measured: Week 2; 2 hour session
Electrodermal Activity (EDA)
Real-time EDA data will be acquired through an E4 Empatica (www.empatica.com) wristband placed on the participants' wrist during the craving induction procedure and imagery intervention conducted at the clinical research facility. the EDA will be computed using the mean differences and peak values of the parameters.
Measured: Week 2; 2 hour session
Temperature
Real-time EDA data will be acquired through an E4 Empatica (www.empatica.com) wristband placed on the participants' wrist during the craving induction procedure and imagery intervention conducted at the clinical research facility. the EDA will be computed using the mean differences and peak values of the parameters.
Measured: Week 2; 2 hour session
Episodic Foresight Score (EFS)
based on the Adapted Autobiographical Interview (AI (Levine et al. 2002; adapted version, Addis, Wong and Schacter (2008)); adapted for this study. The Episodic foresight score (EFS) provides an index of the extent to which participants are personally experiencing an event during mental imagining. This translates into episodic foresight capabilities.
EFS is derived from transcribed mental image descriptions. Details are segmented and categorised as either internal or external. The number of internal details provided an index of the extent to which participants are personally experiencing the event during mental imagining.
High score of external details/ Low score of internal detail signify limited episodic foresight whereas a low score of external detail/high score of internal detail signifies good episodic foresight.
Measured: EFS is assessed during the assessment session (Week 1)
Substance Related Imagery Semi Structured Interview (SRI)
A semi structured interview examining intrusive imagery in substance use. This interview will be used to explore individual craving experiences and help prepare the participant for the imagery intervention.
Consists of 21 questions exploring imagery in substance use. These are divided into three sections: Exploring Substance Related Images, Link to memories and Negative Valence Imagery.
Interview consists of a mix of open-ended questions, visual analogue scales and Yes/No questions.
The interview schedule will be used during the craving experiences interview in the stage 1 assessment.
Measured: Week 1 (Assessment)
Predominance of verbal and imagery-based thoughts visual analogue scale (PV-IT)
Consists of two rating questions to assess the use of imagery versus verbal thought;
'How much of the time has your thinking taken the form of verbal thoughts over the past 5 minutes?', 'How much of the time has your thinking taken the form of mental imagery over the past 5 minutes?',
along with two analogue scales ranging from 'none of the time' to 'all of the time', from 0-9 where 9 indicates all of the time. A higher score indicates frequency of thought in either a visual or verbal modality.
Scale will be administered post craving induction procedure and post imagery intervention.
Measured: Week 2 ( x2; Post Craving Induction; Post Imagery Intervention)
The Positive and Negative affect Schedule (PANAS)
A self-report questionnaire to measure positive and negative affect. The PANAS consists of 20 different affect-related words. Participants indicate if and to what extent they experience the described feeling at the moment of filling in the questionnaire. The scale ranges from 1-5, where 5 indicates a strong experience of a feeling whereas 1 indicates very slightly or not at all.
The PANAS provides two scores, one for negative affect and one for positive affect, where higher scores indicate higher levels of negative and positive affect respectively.
The PANAS will be administered post imagery intervention.
Measured: Week 2 ( Post Imagery Intervention)
Obsessive Compulsive Drug Use Scale (OCDUS)
A self-report questionnaire to measure craving with a focus on the intrusive, obsessive and compulsive characteristics associated to cocaine craving and use.
The OCDUS has 12 questions rated on a 1-5 Likert Scale and is divided into three subscales: Cocaine Thoughts and Interference (six items), Desire and Control (four items); Resistance to Thoughts and Intention (two items).
High scores indicate high levels of cocaine thoughts and interference, high levels of desire and low control over cocaine use and low levels of resistance to cocaine thoughts.
Questionnaire will be administered during Stage 1 assessment.
Measured: Week 1 ( Assessment)
Patient Health Questionnaire (PHQ-9)
A self-administered questionnaire to assess depression severity using the DSM-IV depression criteria. The PHQ-9 consists of 9 items rated on a 4 point scale ( 0-3). The PHQ-9 explores the frequency of problems over the last two weeks where 0 is not at all and 3 is nearly every day.
The total score indicates depression severity as follows: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Questionnaire will be administered during Stage 1 assessment.
Measured: Week 1 (Assessment)
Generalised Anxiety Disorder Assessment (GAD-7)
A self-administered questionnaire to assess general anxiety disorder (GAD) using the DSM-IV criteria. The GAD-7 consists of 7 items rated on a 4 point scale ( 0-3). The GAD-7 explores the frequency of problems over the last two weeks where 0 is not at all and 3 is nearly every day.
The total score (0-21) indicates anxiety severity as follows: : 0-5 mild 6-10 moderate 11-15 moderately severe anxiety ;15-21 severe anxiety.
Questionnaire will be administered during Stage 1 assessment.
Measured: Week 1 (Assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start30 Oct 2018
- Primary completion30 Jan 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- John Marsden, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656653
- Sponsor's protocol ID
- 18?LO/1013
- Acronym
- CIIC
- Status last verified
- Aug 2018
- First submitted
- 22 Aug 2018
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Imagery-based Coping for Cocaine Use Disorder
- ClinicalTrials.gov ID
- NCT03656653
- Acronym / sponsor ID
- CIIC / 18?LO/1013
- Conditions
- Cocaine Use Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 30 Jan 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 4 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pragmatic, 4-week, 4-group, between-subjects, factorial randomised controlled trial conducted at a specialist NHS outpatient addictions clinic and hospital clinical research facility to determine if mental imagery (of past and future positive [recovery oriented] and negative [cocaine aversive] events) can help reduce cue-induced cocaine craving and cocaine use.
Detailed description
Cocaine, a powerful stimulant drug, is used by 2.2% of people aged 16-59 in England and each year about 150.000 people seek help for cocaine use disorder from the NHS or non-governmental organisations (NGO). There are currently no approved medication-assisted treatments or specific psychosocial interventions for CUD. General counselling is offered by the NHS and NGO addiction services, but this is not particularly effective.
The transition from regular cocaine use to cocaine abuse is often marked by intense episodes (binges), which may last several days and are followed by a 'crash' with no or little use. For many people, repeated administration of cocaine over a short duration of time creates vivid episodic memories of euphoria which can inform future craving content. Craving or strong urges are a distinctive feature of CUD and are often reported as involuntary, distressing and uncontrollable.
Research has demonstrated that craving experiences can be voluntarily evoked or elicited by conditioned drug cues in the environment and internal processes such mood or physical sensations. The associations between cues and use are established through classical and instrumental reward-based conditioning and are important for the development and maintenance of CUD. Enhanced attention to cocaine cues develops and remains heightened for at least six months into abstinence.
Craving-related experiences are informed by memories of intense reward, physical sensations and include pro-drug beliefs, appraisals, expectancies and vivid mental imagery. Drug-imagery is often initially pleasurable and affectively charged and can motivate drug-seeking behaviour. If impeded or delayed, drug imagery highlights a deficit and can be experienced as distressing and intrusive. Treatment of intrusive images has been successful in various psychological disorders using imagery rescripting. Imagery rescripting has recently been used in memory-focused cognitive therapy to help reduce cocaine craving. Reducing intrusive image-induced negative affect through positive imagery is important for relieving psychological distress but there is also evidence that aversive imagery may reduce maladaptive approach behaviours.
This will be a pragmatic, 4-week, 2x2, between-subjects, factorial randomised controlled trial. It will be conducted at a specialist NHS outpatient addictions clinic (Lorraine Hewitt House; LHH) operated by South London and Maudsley NHS Foundation trust (SLaM) and at the NIHR Wellcome Trust King's Clinical Research Facility (CRF) at King's College Hospital.
Informed consenting adult participants will be randomised to one of four conditions:
- future-based (prospective) recovery-oriented imagery;
- future-based (prospective) cocaine-aversive imagery;
- past (autobiographical) recovery-oriented imagery; or
- past (autobiographical) cocaine-aversive imagery.
Participants will undergo a craving induction procedure designed to elicit cue-induced craving. In response to elevated craving, participants will be asked to reduce their craving levels using a mental imagery intervention.
Following the procedure in the research facility, participants will be given a digital audio player to take home. This will contain a recording of the imagery condition they are allocated to. Participants will be asked to listen to this recording each day during a 14-day follow-up, and ad libertatem when experiencing cocaine craving. After 14 days participants will be invited for a follow up conducted at the community addictions clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Future-based recovery-oriented imagery | Experimental | Behavioral: Mental Imagery for Craving ReductionMental Imagery for Craving Reduction: mental imagery aimed at describing a future without cocaine use |
| Future-based cocaine-aversive imagery | Experimental | Behavioral: Mental Imagery for Craving ReductionMental Imagery for Craving Reduction: mental imagery aimed at describing a future where cocaine is causing significant distress |
| Past recovery-oriented imagery | Experimental | Behavioral: Mental Imagery for Craving ReductionMental Imagery for Craving Reduction: mental imagery aimed at describing a past event without cocaine use |
| Past cocaine-aversive imagery | Experimental | Behavioral: Mental Imagery for Craving ReductionMental Imagery for Craving Reduction: mental imagery aimed at describing a past event where cocaine use has caused significant distress |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (18 years and over; no upper limit);
- English speaking (to a level sufficient to engage with a psychosocial intervention);
- Current diagnosis for primary CUD alone, with concurrent opiate use disorder or while enrolled in opioid agonist therapy *
- Self-reported regular use of crack cocaine;
- Stated motivation to reduce or quit cocaine use;
Key exclusion criteria (9 listed)
- Current post-traumatic stress disorder (PTCI score >100);
- Suicide attempt in the past 3 months;
- Participants with harmful alcohol consumption (>50 units per week men; >35 units women);
- Cocaine hydrochloride (powder form) users; **
- Non-English Speaking;
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 |
|---|---|---|
| Mental Imagery for Craving Reductiona behavioural mental imagery intervention where participants are asked to generate specific mental images to reduce cue-induced craving for cocaine use disorder | Behavioural | Future-based cocaine-aversive imagery, Future-based recovery-oriented imagery, Past cocaine-aversive imagery, Past recovery-oriented imagery |
Primary outcome
Changes in Number of Days abstinent from Cocaine
Time frame: baseline (Week 0) and at two week-follow up (Week 4)
The primary outcome measure will be number of days abstinent from cocaine (percentage). A higher percentage indicates a higher number of abstinent days from cocaine. This will be expressed as the cumulative distribution function for change (between baseline and follow-up) using a Timeline Follow Back method (calendar prompt). Percentage days abstinent is measured for two weeks before the first assessment and two weeks post craving-induction procedure.
13 secondary outcomes
Change from baseline in Craving Experience Questionnaire Score (CEQ-12)
Time frame: baseline (Week 0) and at two week-follow up (Week 4)
Urine toxicology Screening (UDS)
Time frame: Assessed at two-week follow up (Week 4)
Imagery Monitoring Diary
Time frame: Diary assessed at two-week follow up (Week 4)
Heart Rate Variability (HRV)
Time frame: Week 2; 2 hour session
Electrodermal Activity (EDA)
Time frame: Week 2; 2 hour session
Temperature
Time frame: Week 2; 2 hour session
Episodic Foresight Score (EFS)
Time frame: EFS is assessed during the assessment session (Week 1)
Substance Related Imagery Semi Structured Interview (SRI)
Time frame: Week 1 (Assessment)
Predominance of verbal and imagery-based thoughts visual analogue scale (PV-IT)
Time frame: Week 2 ( x2; Post Craving Induction; Post Imagery Intervention)
The Positive and Negative affect Schedule (PANAS)
Time frame: Week 2 ( Post Imagery Intervention)
Obsessive Compulsive Drug Use Scale (OCDUS)
Time frame: Week 1 ( Assessment)
Patient Health Questionnaire (PHQ-9)
Time frame: Week 1 (Assessment)
Generalised Anxiety Disorder Assessment (GAD-7)
Time frame: Week 1 (Assessment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- 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.
John Marsden principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Imagery for Craving Reduction in people with Cocaine Use Disorder, run by King's College London at 1 site in United Kingdom.
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 5 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: status not confirmed, as of the sponsor's last update on 28 Feb 2019. 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 Kingdom. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Camille Goetz (00447928331625, camille.e.goetz@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Number of Days abstinent from Cocaine (time frame: baseline (Week 0) and at two week-follow up (Week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2019.