Substance Use DisordersPhase 2NCT03980184
Guanfacine to Improve Substance Use Outcomes in Women
A Phase 2 study testing Guanfacine and Behavioral Counseling in people with Substance Use Disorders, run by Yale University at 1 site in United States.
Trial summary
Hypothesis: Guanfacine (GUA) (3mg/day) will reduce drug craving, improve cognitive flexibility and result in associated lower drug use in women with substance use disorder (SUD) in an outpatient clinical setting. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Guanfacine and Behavioral Counseling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 30 Nov 2022
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 100 treatment seeking women
- Ages 18-70 years
- Body mass index (BMI) of 18-35
- Meet current DSM-V criteria for co-occurring SUDs, with primary DSM-V cocaine or primary DSM-V opioid use disorder AND co-occurring cannabis or alcohol or nicotine use disorders;
- Positive drug urine toxicology screens for primary addictive disorder during a 2-week intake assessment period
- Good health as verified by screening examination
- Able to read English and complete study evaluations
- Able to provide informed written and verbal consent
Who cannot join
- Meet criteria for physiological dependence on alcohol requiring medical detoxification
- Regular use of anti-hypertensives, anti-arrythmics, antiretroviral medications, and medications that would interact with Guanfacine and be contraindicated as per study physician;
- Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania)
- Significant underlying medical conditions which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study; Specifically hepatic and renal impairment as per liver enzymes at 3X the normal limit, or BUN>50mg or BUN:Cr > 10:1.
- Hypotensive women with sitting blood pressure below 100/50 mmHG
- Women who are pregnant, nursing or refuse to use a reliable form of birth control
- EKG evidence at baseline screening of any clinically significant conduction abnormalities, including a Bazlett's QT c>470 msec for women.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Yale Stress Center: Yale University
New Haven, Connecticut, 06519
About this study
Official title: The Use of Guanfacine (GUA) (3mg/Day) to Reduce Drug Craving, Improve Cognitive Flexibility and Result in Associated Lower Drug Use in Women With Substance Use Disorder (SUD).
Hypothesis: Guanfacine (GUA) (3mg/day) will reduce drug craving, improve cognitive flexibility and result in associated lower drug use in women with substance use disorder (SUD) in an outpatient clinical setting.
Read the detailed description
This study proposes to extend previous Phase I experimental work to address the following specific aims: (1) assess GUA's target engagement of drug craving and cognitive flexibility in a laboratory challenge session and in a 10-week outpatient clinical study, (2) demonstrate target validation by showing that reduced drug craving and improved cognitive flexibility will predict lower drug use outcomes during the 10-week clinical trial in SUD women, and finally, (3) evaluate data replication and scalability of GUA target effects across two clinical sites (Yale and SUNY-Stony Brook).
- Conditions
- Substance Use Disorders
- Being tested
- Guanfacine, Behavioral Counseling
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuanfacineDrug
Also called Tenex,
Guanfacine 3mg/day Versus Placebo
Behavioral CounselingOther
Also called Manualized Drug Counseling
placebo
| Study group | Role | What they receive |
|---|---|---|
| Study Medication | Experimental | guanfacine 3mg/day (GUA) Receives: Drug: Guanfacine; Other: Behavioral Counseling |
| placebo | Placebo comparator | placebo (PBO) Receives: Drug: Guanfacine; Other: Behavioral Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Drug Use With Substance Use Calendar
Days of any drug use during the 10 week period (assessed daily and weekly via self report). Data presented here is the average between week 10 and week 1.
Measured: 10 weeks
Change in Abstinence Days
Substance use calendar self report of daily drug use during 10 week treatment periods. Data presented here is the average between week 10 and week 1.
Measured: 10 weeks
Secondary outcomes (2)
Change in Average Drug Craving
Sum of average drug craving measured using Craving Questionnaires for cocaine, opiates, alcohol, nicotine and cannabis.The possible range for the average craving measure is 0 - 100. A higher score on the measure = greater avg drug craving.
Measured: 10 weeks
Number of Participants With Treatment Emergent Adverse Event
The Systematic Assessment of Treatment Emergent Events (SAFTEE) Questionnaire will be used to assess adverse events weekly during the trial. Data presented here is the number of participants that had any adverse events while on study.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start1 Nov 2019
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
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 Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized double blind, placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, RAJITA SINHA, Yale University
- Investigators
- Rajita Sinha, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980184
- Sponsor's protocol ID
- 2000023100
- Other IDs
- 1R01DA047094-01A1
- Status last verified
- Mar 2024
- First submitted
- 29 Mar 2019
- Last updated
- 20 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Guanfacine (GUA) (3mg/Day) to Reduce Drug Craving, Improve Cognitive Flexibility and Result in Associated Lower Drug Use in Women With Substance Use Disorder (SUD).
- ClinicalTrials.gov ID
- NCT03980184
- Acronym / sponsor ID
- 2000023100
- Conditions
- Substance Use Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Posted 8 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: Guanfacine (GUA) (3mg/day) will reduce drug craving, improve cognitive flexibility and result in associated lower drug use in women with substance use disorder (SUD) in an outpatient clinical setting.
Detailed description
This study proposes to extend previous Phase I experimental work to address the following specific aims: (1) assess GUA's target engagement of drug craving and cognitive flexibility in a laboratory challenge session and in a 10-week outpatient clinical study, (2) demonstrate target validation by showing that reduced drug craving and improved cognitive flexibility will predict lower drug use outcomes during the 10-week clinical trial in SUD women, and finally, (3) evaluate data replication and scalability of GUA target effects across two clinical sites (Yale and SUNY-Stony Brook).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized double blind, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Study Medication | Experimental | Drug: Guanfacine, Other: Behavioral Counselingguanfacine 3mg/day (GUA) |
| placebo | Placebo comparator | Drug: Guanfacine, Other: Behavioral Counselingplacebo (PBO) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 100 treatment seeking women
- Ages 18-70 years
- Body mass index (BMI) of 18-35
- Meet current DSM-V criteria for co-occurring SUDs, with primary DSM-V cocaine or primary DSM-V opioid use disorder AND co-occurring cannabis or alcohol or nicotine use disorders;
- Positive drug urine toxicology screens for primary addictive disorder during a 2-week intake assessment period
Key exclusion criteria (7 listed)
- Meet criteria for physiological dependence on alcohol requiring medical detoxification
- Regular use of anti-hypertensives, anti-arrythmics, antiretroviral medications, and medications that would interact with Guanfacine and be contraindicated as per study physician;
- Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania)
- Significant underlying medical conditions which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study; Specifically hepatic and renal impairment as per liver enzymes at 3X the normal limit, or BUN>50mg or BUN:Cr > 10:1.
- Hypotensive women with sitting blood pressure below 100/50 mmHG
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 |
|---|---|---|
| GuanfacineAlso: Tenex,Guanfacine 3mg/day Versus Placebo | Drug | Study Medication, placebo |
| Behavioral CounselingAlso: Manualized Drug Counselingplacebo | Other | Study Medication, placebo |
Primary outcome
Change in Drug Use With Substance Use Calendar
Time frame: 10 weeks
Days of any drug use during the 10 week period (assessed daily and weekly via self report). Data presented here is the average between week 10 and week 1.
Change in Abstinence Days
Time frame: 10 weeks
Substance use calendar self report of daily drug use during 10 week treatment periods. Data presented here is the average between week 10 and week 1.
2 secondary outcomes
Change in Average Drug Craving
Time frame: 10 weeks
Number of Participants With Treatment Emergent Adverse Event
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- 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.
Rajita Sinha, PhD principal investigator
Yale University
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 Guanfacine and Behavioral Counseling in people with Substance Use Disorders, run by Yale University 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 8 inclusion and 7 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 20 Mar 2024. 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 8 Jan 2024). 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 in Drug Use With Substance Use Calendar (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2024.