Opiate AddictionPhase 2NCT01605539
Acute and Short-term Effects of Cannabidiol Admin on Cue-induced Craving in Drug-abstinent Heroin Dependent Humans
A Phase 2 study testing Cannabidiol 400 and Cannabidiol 800 in people with Opiate Addiction, run by Hurd,Yasmin, Ph.D. at 1 site in United States.
Trial summary
Despite the current available therapies for opioid-dependent patients, most patients relapse. This research project focuses on the development of a novel compound, cannabidiol, to modulate opioid craving in humans based on animal models showing its selective effectiveness to inhibit drug-seeking behavior. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Opiate Addiction
- What is being tested?
- Cannabidiol 400 and Cannabidiol 800
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Oct 2013
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be between 21 and 65 years old
- Must have an opiate dependence that meets criteria set in the Structured Clinical Interview for DSM-IV(SCID-IV) over the last three months
- No opioid use in the past 7 days (will be verified via urine drug screen and opiate metabolite test)
Who cannot join
- Using any psychoactive drug (other than nicotine) any time up to test session 3
- Having a diagnosis of drug dependence (except for heroin or nicotine) in the past 3 months, based on the SCID-IV interview criteria
- Being maintained on methadone or buprenorphine, or taking opioid antagonists such as naltrexone
- Having a positive a drug screen
- Showing signs of acute heroin withdrawal symptoms
- Having medical conditions, including Axis I psychiatric conditions under DSM-IV (examined using the Mini International Neuropsychiatric Interview [MINI])
Show all 12Show fewer
- Having a a history of cardiac disease, arrhythmias, head trauma, and seizures
- Having a history of hypersensitivity to cannabinoids
- Arriving to the study site visibly intoxicated as determined by a clinical evaluation for signs and symptoms of intoxication and as verified by a drug screen
- Participating in a another pharmacotherapeutic trial in the past 3 months
- Being pregnant of breastfeeding
- Not using or irregularly using appropriate methods of contraception such as hormonal contraceptives (e.g., Depo-Provera, Nuva-Ring), an intrauterine device (IUD), or double barrier method (combination of any two barrier methods used simultaneously, e.g., condoms, spermicide, diaphragms)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Medical Center
New York, New York, 10029
About this study
Official title: Cannabidiol as Treatment Intervention for Opioid Relapse
Despite the current available therapies for opioid-dependent patients, most patients relapse. This research project focuses on the development of a novel compound, cannabidiol, to modulate opioid craving in humans based on animal models showing its selective effectiveness to inhibit drug-seeking behavior. The development of a targeted treatment for opioid relapse would be of tremendous medical and public health value.
Read the detailed description
Opioid abuse is a significant global public health problem. Of the more than one million people suffering today from opiate dependency, less than a quarter of such individuals receive treatment. Pharmacotherapeutic approaches traditionally have targeted mu opioid receptors since heroin and its metabolites bind with highest affinity to this receptor subtype. Although such treatment strategies have improved substance abuse outcomes, they do not effectively block opiate craving and thus are still associated with high rates of relapse. Using a strategy of indirectly regulating neural systems to modulate opioid-related behavior, our preclinical rodent studies consistently demonstrated that cannabidiol (CBD), a nonpsychoactive component of cannabis, specifically inhibited cue-induced heroin-seeking behavior. CBD's selective effect on drug-seeking behavior was pronounced after 24 hrs and endured even two weeks after the last drug administration following short-term CBD exposure. The fact that drug craving is generally triggered by exposure to conditioned cues suggests that CBD might be an effective treatment for heroin craving, specially given its protracted impact on behavior. CBD has already been shown in Phase I of our study and in various clinical studies to be well tolerated with a wide safety margin in human subjects. CBD thus represents a strong candidate for the development as a potential therapeutic agent in humans for opioid craving and relapse prevention. It is the goal of this second exploratory phase of the project to characterize the effects of CBD administration on cue-induced craving in drug-abstinent heroin-dependent subjects using a random double blind design during a post-acute (greater than 6 days since last use) heroin withdrawal period. Study participants will be administered CBD during 3 test sessions and studied for the effects on cue-induced craving during those sessions as well as one week after the final CBD administration on the final test day (session 4).
- Conditions
- Opiate Addiction
- Being tested
- Cannabidiol 400, Cannabidiol 800, Control
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol 400Drug
Also called CBD
Subjects in Arm CBD 400 will receive 400mg of Cannabidiol in each of the three test sessions
Cannabidiol 800Drug
Also called CBD
Subjects in Arm CBD 800 will receive 800mg of Cannabidiol in each of the three test sessions
ControlDrug
Also called CBD
Subjects will receive a harmless, inactive pill to compare and validate the results of the other arms of the study
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Subjects will receive pills that resemble the Cannabidiol capsule but do not have have its properties. Receives: Drug: Control |
| Cannabidiol 400 | Experimental | Subjects in Arm Cannabidiol 400 will receive 400 mg of cannabidiol Receives: Drug: Cannabidiol 400 |
| Cannabidiol 800 | Experimental | Subjects in Arm Cannabidiol 800 will receive 800mg of cannabidiol Receives: Drug: Cannabidiol 800 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue or Post-neutral - Via the Visual Analog Scale for Craving (VASC)
The VASC will be administered to assess potential variations in the subjective craving effects associated with heroin. Following the administration of the investigational drug, craving induced in response to the cue sessions and neutral cue sessions in the clinic will be measured. In this way, changes in craving from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) within each test visit) will be measured and compared. Scale range: 0 (no craving) - 10 (extreme craving).
**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. The same questionnaires will be administered immediately following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test
Measured: VASC: test visits I, II and IV - baseline 1, post cue (PC), baseline 2, post neutral cue (PN)
Changes in Out-of-Clinic Craving (From Pre-Dose to Approximately 6 Hours Post-Dose for Test Visits I and II; and From Pre-Dose Test Visit I to Pre-Cue Test Visit IV) - Via the Heroin Craving Questionnaire (HCQ)
Subjects will be asked to complete the short version of the HCQ on their own time at home and bring it with them when they return for their next visit. Upon arrival to the clinic, subjects will also complete an HCQ with the coordinator to assess daily baseline cravings. This questionnaire will help us assess changes in craving generated outside of the clinical laboratory session from test visit 1 through test visit 4. Scale: 1 (strongly disagree) - 7 (strongly agree). Total Score Range: 14 (less cravings) - 98 (more cravings).
** The baseline measure for this outcome will be measured at the beginning of test session I prior to the administration of CBD/Placebo. Test measures will be taken approximately 6 hours following each dose for test sessions I, II and III. The final measure will be taken at test session IV, at the beginning of the session.
Measured: Test I and II: Change from pre-dose to approx. 6 hours post-dose; Change from pre-dose test visit I to pre-cue test visit IV
Secondary outcomes (7)
Vital Signs - Blood Pressure
Blood pressure (mmHg) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.
**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Blood pressure will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV.
Measured: Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)
Visual Analog Scale for Anxiety (VASA)
Questionnaires will be used to measure subjective responses. Anxiety will be assessed using a visual analog scale for anxiety (VASA). Scale: 0 (not at all anxious) - 10 (extremely anxious).
**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken for each variable. The same variables will be measured following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV.
Measured: Test visit I, II and IV: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)
The Positive and Negative Affect Schedule (PANAS) - Positive Affect Schedule (PAS) Data
Questionnaires will be used to measure subjective responses. The Positive and Negative Affect Schedule will allow us to obtain positive and negative affect measures and observe their changes from baseline over the course of the cue-induced craving session. Scale: 0 (only slightly or not at all) - 5 (extremely). Total Score Range for Positive Affect Assessment (PAS): 10 (minimum) - 50 (maximum). Higher score reflects stronger positive affect.
**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken for each variable. The same variables will be measured following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV.
Measured: Test session 1, 2, and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)
The Positive and Negative Affect Schedule (PANAS) - Negative Affect Schedule (NAS) Data
Questionnaires will be used to measure subjective responses. The Positive and Negative Affect Schedule will allow us to obtain positive and negative affect measures and observe their changes from baseline over the course of the cue-induced craving session. Scale: 0 (only slightly or not at all) - 5 (extremely). Total Score Range for Negative Affect Assessment (NAS): 10 (minimum) - 50 (maximum). Higher score reflects stronger negative affect.
**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken for each variable. The same variables will be measured following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV.
Measured: Test session 1, 2, and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)
Vital Signs - Heart Rate
Heart rate (in beats/min) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.
**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Heart rate will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV.
Measured: Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)
Vital Signs - Respiratory Rate
Respiratory rate (in breaths/min) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.
**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Respiratory rate will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV.
Measured: Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)
Vital Signs - Temperature
Temperature (in degrees Fahrenheit) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.
**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Temperature will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV.
Measured: Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2013
- Study completionOct 2013
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.
- Other trials for Opiate AddictionStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hurd,Yasmin, Ph.D.
- Responsible party
- Principal investigator, Yasmin Hurd, Hurd,Yasmin, Ph.D.
- Investigators
- Yasmin Hurd, Ph.D., Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605539
- Sponsor's protocol ID
- R21 DA027781(2)
- Other IDs
- R21DA027781
- Status last verified
- Jul 2020
- First submitted
- 2 May 2012
- Last updated
- 11 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabidiol as Treatment Intervention for Opioid Relapse
- ClinicalTrials.gov ID
- NCT01605539
- Acronym / sponsor ID
- R21 DA027781(2)
- Conditions
- Opiate Addiction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hurd,Yasmin, Ph.D.
- Study start
- May 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 25 May 2012 (estimated)
- Results
- Posted 28 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite the current available therapies for opioid-dependent patients, most patients relapse. This research project focuses on the development of a novel compound, cannabidiol, to modulate opioid craving in humans based on animal models showing its selective effectiveness to inhibit drug-seeking behavior. The development of a targeted treatment for opioid relapse would be of tremendous medical and public health value.
Detailed description
Opioid abuse is a significant global public health problem. Of the more than one million people suffering today from opiate dependency, less than a quarter of such individuals receive treatment. Pharmacotherapeutic approaches traditionally have targeted mu opioid receptors since heroin and its metabolites bind with highest affinity to this receptor subtype. Although such treatment strategies have improved substance abuse outcomes, they do not effectively block opiate craving and thus are still associated with high rates of relapse. Using a strategy of indirectly regulating neural systems to modulate opioid-related behavior, our preclinical rodent studies consistently demonstrated that cannabidiol (CBD), a nonpsychoactive component of cannabis, specifically inhibited cue-induced heroin-seeking behavior. CBD's selective effect on drug-seeking behavior was pronounced after 24 hrs and endured even two weeks after the last drug administration following short-term CBD exposure. The fact that drug craving is generally triggered by exposure to conditioned cues suggests that CBD might be an effective treatment for heroin craving, specially given its protracted impact on behavior. CBD has already been shown in Phase I of our study and in various clinical studies to be well tolerated with a wide safety margin in human subjects. CBD thus represents a strong candidate for the development as a potential therapeutic agent in humans for opioid craving and relapse prevention. It is the goal of this second exploratory phase of the project to characterize the effects of CBD administration on cue-induced craving in drug-abstinent heroin-dependent subjects using a random double blind design during a post-acute (greater than 6 days since last use) heroin withdrawal period. Study participants will be administered CBD during 3 test sessions and studied for the effects on cue-induced craving during those sessions as well as one week after the final CBD administration on the final test day (session 4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: ControlSubjects will receive pills that resemble the Cannabidiol capsule but do not have have its properties. |
| Cannabidiol 400 | Experimental | Drug: Cannabidiol 400Subjects in Arm Cannabidiol 400 will receive 400 mg of cannabidiol |
| Cannabidiol 800 | Experimental | Drug: Cannabidiol 800Subjects in Arm Cannabidiol 800 will receive 800mg of cannabidiol |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be between 21 and 65 years old
- Must have an opiate dependence that meets criteria set in the Structured Clinical Interview for DSM-IV(SCID-IV) over the last three months
- No opioid use in the past 7 days (will be verified via urine drug screen and opiate metabolite test)
Key exclusion criteria (12 listed)
- Using any psychoactive drug (other than nicotine) any time up to test session 3
- Having a diagnosis of drug dependence (except for heroin or nicotine) in the past 3 months, based on the SCID-IV interview criteria
- Being maintained on methadone or buprenorphine, or taking opioid antagonists such as naltrexone
- Having a positive a drug screen
- Showing signs of acute heroin withdrawal symptoms
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 |
|---|---|---|
| Cannabidiol 400Also: CBDSubjects in Arm CBD 400 will receive 400mg of Cannabidiol in each of the three test sessions | Drug | Cannabidiol 400 |
| Cannabidiol 800Also: CBDSubjects in Arm CBD 800 will receive 800mg of Cannabidiol in each of the three test sessions | Drug | Cannabidiol 800 |
| ControlAlso: CBDSubjects will receive a harmless, inactive pill to compare and validate the results of the other arms of the study | Drug | Control |
Primary outcome
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue or Post-neutral - Via the Visual Analog Scale for Craving (VASC)
Time frame: VASC: test visits I, II and IV - baseline 1, post cue (PC), baseline 2, post neutral cue (PN)
The VASC will be administered to assess potential variations in the subjective craving effects associated with heroin. Following the administration of the investigational drug, craving induced in response to the cue sessions and neutral cue sessions in the clinic will be measured. In this way, changes in craving from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) within each test visit) will be measured and compared. Scale range: 0 (no craving) - 10 (extreme craving). **For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. The same questionnaires will be administered immediately following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test
Changes in Out-of-Clinic Craving (From Pre-Dose to Approximately 6 Hours Post-Dose for Test Visits I and II; and From Pre-Dose Test Visit I to Pre-Cue Test Visit IV) - Via the Heroin Craving Questionnaire (HCQ)
Time frame: Test I and II: Change from pre-dose to approx. 6 hours post-dose; Change from pre-dose test visit I to pre-cue test visit IV
Subjects will be asked to complete the short version of the HCQ on their own time at home and bring it with them when they return for their next visit. Upon arrival to the clinic, subjects will also complete an HCQ with the coordinator to assess daily baseline cravings. This questionnaire will help us assess changes in craving generated outside of the clinical laboratory session from test visit 1 through test visit 4. Scale: 1 (strongly disagree) - 7 (strongly agree). Total Score Range: 14 (less cravings) - 98 (more cravings). ** The baseline measure for this outcome will be measured at the beginning of test session I prior to the administration of CBD/Placebo. Test measures will be taken approximately 6 hours following each dose for test sessions I, II and III. The final measure will be taken at test session IV, at the beginning of the session.
7 secondary outcomes
Vital Signs - Blood Pressure
Time frame: Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)
Visual Analog Scale for Anxiety (VASA)
Time frame: Test visit I, II and IV: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)
The Positive and Negative Affect Schedule (PANAS) - Positive Affect Schedule (PAS) Data
Time frame: Test session 1, 2, and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)
The Positive and Negative Affect Schedule (PANAS) - Negative Affect Schedule (NAS) Data
Time frame: Test session 1, 2, and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)
Vital Signs - Heart Rate
Time frame: Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)
Vital Signs - Respiratory Rate
Time frame: Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)
Vital Signs - Temperature
Time frame: Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Yasmin Hurd, Ph.D. principal investigator
Icahn School of Medicine at Mount Sinai
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 Cannabidiol 400 and Cannabidiol 800 in people with Opiate Addiction, run by Hurd,Yasmin, Ph.D. 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 3 inclusion and 12 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 11 Aug 2020. 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. Some participants in this study may receive a placebo. 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 28 Nov 2016). 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?
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue or Post-neutral - Via the Visual Analog Scale for Craving (VASC) (time frame: VASC: test visits I, II and IV - baseline 1, post cue (PC), baseline 2, post neutral cue (PN)). 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?
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 11 Aug 2020.