Cannabis DependencePhase 2NCT02210195
Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence
A Phase 2 study testing aprepitant and Manual-guided behavioral counseling in people with Cannabis Dependence and Alcohol Dependence, run by The Scripps Research Institute at 1 site in United States.
Trial summary
The primary aim of the supplemental study is to provide POC testing of aprepitant as a treatment for comorbid alcohol and cannabis dependence. The data analysis plan specified in the parent grant will likewise be applied to the supplemental project to test for effects of aprepitant vs placebo on measures of alcohol… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cannabis Dependence, Alcohol Dependence, Cannabis Use Disorder
- What is being tested?
- aprepitant and Manual-guided behavioral counseling
- 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2014to 19 Dec 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females from 18-70 years of age
- Meets DSM IV criteria for current alcohol and cannabis dependence
- Seeking research-based outpatient treatment for alcohol and cannabis dependence that involves daily oral medication
- Negative BAC and a CIWA score < 9 at randomization
Who cannot join
- Significant medical disorders or use of medications that will increase potential risk or influence study outcomes
- Females who are pregnant, nursing or who are sexually active with child-bearing potential and refuse to use an effective, non hormonal method of birth control during the study and for up to 4 weeks after study termination• Treatment with an investigational drug during the previous month
- Prior treatment with NK1 antagonists
- Participants for whom treatment is being mandated by a legal authority• Inability to understand and/or comply with the provisions of the protocol and consent form
Trial locations and contacts
1 site in 1 country.
United States1 site
The Scripps Research Institute
La Jolla, California, 92037
About this study
The primary aim of the supplemental study is to provide POC testing of aprepitant as a treatment for comorbid alcohol and cannabis dependence. The data analysis plan specified in the parent grant will likewise be applied to the supplemental project to test for effects of aprepitant vs placebo on measures of alcohol and cannabis use and protracted withdrawal. The primary hypothesis is that subjects treated with aprepitant will have significantly less alcohol and marijuana use than subjects treated with placebo.
Read the detailed description
Consistent with the scope and methods of the parent grant, this was a randomized, double-blind, placebo-controlled, parallel groups, Phase II, single-site, 8-week clinical trial of aprepitant 125 mg/d or placebo. Participants were 20 outpatients seeking treatment for concurrent alcohol and cannabis dependence. All participants received weekly protocol-specific counseling. Research assessments occurred weekly through the treatment phase of the 8-week study. Post treatment follow-up assessments occurred at Weeks 9 and 12.
- Being tested
- aprepitant, Placebo, Manual-guided behavioral counseling
- Keywords
- Cannabis Treatment, Alcohol Treatment, Alcohol-Related Disorders, Cannabis-Related Disorders, Substance-Related Disorders, Emend, NK1 receptor antagonist, Alcohol, Cannabis, aprepitant
- Medical subject headings
- Marijuana Abuse, Alcoholism, Alcohol-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aprepitantDrug
Also called Emend
125 mg daily for 8 weeks.
PlaceboDrug
Placebo daily for 8 weeks.
Manual-guided behavioral counselingBehavioural
Also called Manual-guided therapy
Standardized manual-guided behavioral counseling performed 1 time per week for 8 weeks in conjunction with study drug or placebo.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: aprepitant 125 mg/day | Active comparator | 125 mg aprepitant daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling. Receives: Drug: aprepitant; Behavioral: Manual-guided behavioral counseling |
| Placebo 125mg/d | Placebo comparator | Matched placebo pill given daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling. Receives: Drug: Placebo; Behavioral: Manual-guided behavioral counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8
Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use. Change = (Week 8 value - Week 0 value).
Measured: Week 0 and Week 8
Change From Week 0 in Drinking Quantity and Frequency Using Drinks Per Week at Week 8
Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 8 - Week 0). More negative values indicate less use of alcohol.
Measured: Week 0 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study start4 Sep 2014
- Primary completion19 Dec 2016
- Study completion19 Dec 2016
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 Cannabis DependenceStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Scripps Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Barbara J. Mason, The Scripps Research Institute
- Investigators
- Barbara J. Mason, Ph.D., Principal investigator, The Scripps Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210195
- Sponsor's protocol ID
- DA030988-04S1
- Other IDs
- R01DA030988-04S1
- Status last verified
- Jul 2017
- First submitted
- 31 Jul 2014
- Last updated
- 2 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence
- ClinicalTrials.gov ID
- NCT02210195
- Acronym / sponsor ID
- DA030988-04S1
- Keywords
- Cannabis Treatment, Alcohol Treatment, Alcohol-Related Disorders, Cannabis-Related Disorders, Substance-Related Disorders, Emend, NK1 receptor antagonist, Alcohol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Scripps Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 Sep 2014 (actual)
- Primary completion
- 19 Dec 2016 (actual)
- Study completion
- 19 Dec 2016 (actual)
- First posted
- 6 Aug 2014 (estimated)
- Results
- Posted 2 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of the supplemental study is to provide POC testing of aprepitant as a treatment for comorbid alcohol and cannabis dependence. The data analysis plan specified in the parent grant will likewise be applied to the supplemental project to test for effects of aprepitant vs placebo on measures of alcohol and cannabis use and protracted withdrawal. The primary hypothesis is that subjects treated with aprepitant will have significantly less alcohol and marijuana use than subjects treated with placebo.
Detailed description
Consistent with the scope and methods of the parent grant, this was a randomized, double-blind, placebo-controlled, parallel groups, Phase II, single-site, 8-week clinical trial of aprepitant 125 mg/d or placebo. Participants were 20 outpatients seeking treatment for concurrent alcohol and cannabis dependence. All participants received weekly protocol-specific counseling. Research assessments occurred weekly through the treatment phase of the 8-week study. Post treatment follow-up assessments occurred at Weeks 9 and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: aprepitant 125 mg/day | Active comparator | Drug: aprepitant, Behavioral: Manual-guided behavioral counseling125 mg aprepitant daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling. |
| Placebo 125mg/d | Placebo comparator | Drug: Placebo, Behavioral: Manual-guided behavioral counselingMatched placebo pill given daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females from 18-70 years of age
- Meets DSM IV criteria for current alcohol and cannabis dependence
- Seeking research-based outpatient treatment for alcohol and cannabis dependence that involves daily oral medication
- Negative BAC and a CIWA score < 9 at randomization
Key exclusion criteria (4 listed)
- Significant medical disorders or use of medications that will increase potential risk or influence study outcomes
- Females who are pregnant, nursing or who are sexually active with child-bearing potential and refuse to use an effective, non hormonal method of birth control during the study and for up to 4 weeks after study termination• Treatment with an investigational drug during the previous month
- Prior treatment with NK1 antagonists
- Participants for whom treatment is being mandated by a legal authority• Inability to understand and/or comply with the provisions of the protocol and consent form
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 |
|---|---|---|
| aprepitantAlso: Emend125 mg daily for 8 weeks. | Drug | Experimental: aprepitant 125 mg/day |
| PlaceboPlacebo daily for 8 weeks. | Drug | Placebo 125mg/d |
| Manual-guided behavioral counselingAlso: Manual-guided therapyStandardized manual-guided behavioral counseling performed 1 time per week for 8 weeks in conjunction with study drug or placebo. | Behavioural | Experimental: aprepitant 125 mg/day, Placebo 125mg/d |
Primary outcome
Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8
Time frame: Week 0 and Week 8
Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use. Change = (Week 8 value - Week 0 value).
Change From Week 0 in Drinking Quantity and Frequency Using Drinks Per Week at Week 8
Time frame: Week 0 and Week 8
Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 8 - Week 0). More negative values indicate less use of alcohol.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Barbara J. Mason, Ph.D. principal investigator
The Scripps Research Institute
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 aprepitant and Manual-guided behavioral counseling in people with Cannabis Dependence and Alcohol Dependence, run by The Scripps Research Institute 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 4 inclusion and 4 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 2 Aug 2017. 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 2 Aug 2017). 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?
Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8 (time frame: Week 0 and Week 8). 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 2 Aug 2017.