Phase 2
Completed N=74
Guanfacine to Improve Substance Use Outcomes in Women
Source: ClinicalTrials.gov NCT03980184 ↗Enrolled (actual)
74
Serious AEs
8.6%
Results posted
Jan 2024
Primary outcomePrimary: Change in Drug Use With Substance Use Calendar — -6.35; -5.61 days — p=0.08
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Drug Use With Substance Use Calendar |
-6.35; -5.61 | 0.08 |
| PRIMARY Change in Abstinence Days |
0.28; -0.12 | <.001 sig |
| SECONDARY Change in Average Drug Craving |
-14.6; -21.9 | 0.703 |
| SECONDARY Number of Participants With Treatment Emergent Adverse Event |
21; 15 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03980184). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.